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Lower risk Medical device recall · FDA · Published December 1, 2023

Howmedica Scorpio-Flex Knee Implant Recall: Oxidation Risk in Older Units

Howmedica recalls older Scorpio-Flex knee implants (part 72-16-0910) due to potential oxidation in UHMWPE material that may affect performance. Affected units have lot numbers starting with 43103101.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0885-2024Medical deviceHowmedica ›
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Contact the company

Recalling firmHowmedica Osteonics Corp.325 Corporate Dr · Mahwah, NJ 07430-2006
✎ GovInfoNow plain-language explainer

Howmedica is recalling older Scorpio-Flex knee implants that may have oxidation issues in the UHMWPE material. This could affect the implant's performance over time, though serious injury risk is not specified in the recall. Read more at govinfonow.com/recall/56653-howmedica-scorpio-flex-knee-implant-recall-oxidation-risk-in-older.

Source Summary by GovInfoNow · govinfonow.com/recall/56653-howmedica-scorpio-flex-knee-implant-recall-oxidation-risk-in-older · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0885-2024

Cite this page

“Howmedica Scorpio-Flex Knee Implant Recall: Oxidation Risk in Older Units.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/56653-howmedica-scorpio-flex-knee-implant-recall-oxidation-risk-in-older. Based on FDA recall #Z-0885-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0885-2024%22&limit=1).

The FDA announced on Dec. 1, 2023, that Howmedica Osteonics Corp. is recalling the Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- knee replacement implant due to potential elevated oxidation levels in aged raw material. The agency issued recall number Z-0885-2024 for the Class II device.

How to tell if you have it

  • Brand: Howmedica
  • Product: Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy-
  • Part Number: 72-16-0910
  • UPC: 07613154020645
  • Lot Numbers: 43103101

The hazard

The product was manufactured using UHMWPE raw material over five years of age, which has the potential for elevated levels of oxidation. Oxidation within UHMWPE can impact its material properties.

Context

GovInfoNow's records show Howmedica Osteonics Corp. has 46 other recalls on record since July 21, 2017. Other recent recalls of similar products include the Howmedica TRIDENT 0° POLY INSERT (July 30, 2026), the Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and the Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026). Other recent recalls of similar products include the Paragon 28 Custom Foot Implant Recall (July 10, 2026), the Kico Knee Innovation Arvis Hip & Knee 2.0 Instrument Set Recall (April 23, 2026), and the Burlington Medical Vest Recall (Feb. 11, 2026).

How to tell if you have this one

Check for part number 72-16-0910 and lot numbers starting with 43103101 on the implant. The product is intended for knee replacement surgery and was sold with specific lot numbers.

  • Brand
    Howmedica
  • Product
    Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy
  • Category
    Medical device
FDA recall event · 58 products

All 58 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added: Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Recall numberProduct, codes & lotsQuantity
Z-0869-2024SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026; GTIN: 07613327033779 Lot Numbers: PVDY TEN1 AMN1 V644 MHHE 4T1K V355 55LK JR6R94 units US; 131 units OUS
Z-0870-2024SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028; GTIN: 07613327033793 Lot Numbers: A59N, EP7J , X79L52 units US; 20 units OUS
Z-0871-2024SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0030; GTIN: 07613327033809 Lot Numbers: PD99, 6AHH, RY3J77 units US; 2 units OUS
Z-0872-2024SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032; GTIN: 07613327033823 Lot Numbers: 6LR4, R14V, N88270 units US
Z-0873-2024SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515; GTIN: 07613327034042 Lot Numbers: WK4PX0—
Z-0874-2024SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524; GTIN: 07613327034073 Lot Numbers: K349TP—
Z-0875-2024SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321; GTIN: 07613327034349 Lot Numbers: TA21X9—
Z-0876-2024SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0510; GTIN: 07613327034363 Lot Numbers: H43RDK, WR1RE3, 768NEY, 4J13P1—
Z-0877-2024SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512; GTIN: 07613327034790 Lot Numbers: 5M6LM1—
Z-0878-2024SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514; GTIN: 07613327034820 Lot Numbers: 482LM8, HH43K7—
Z-0879-2024SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516; GTIN: 07613327034806 Lot Numbers: TN1746, KK82WY—
Z-0880-2024SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518; GTIN: 07613327034813 Lot Numbers: 9P8360, AK83935 units US
Z-0881-2024SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521; GTIN: 07613327034837 Lot Numbers: VA0X4T—
Z-0882-2024SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524; GTIN: 07613327034844 Lot Numbers: V68WW1,93400601—
Z-0883-2024Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- Intended for knee replacement Part Number: 72-15-0324; GTIN: 07613154020133 Lot Numbers: 53867101—
Z-0884-2024Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908; GTIN: 07613154020638 Lot Numbers: 429686015 units US
Z-0885-2024Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910; GTIN: 07613154020645 Lot Numbers: 431031019 units US
Z-0886-2024SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110; GTIN: 07613327050288 Lot Numbers: 79E0, 274P, WEKJ, LH82, 33ND61 units US; 46 units OUS
Z-0887-2024SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #5 -Intended for knee replacement Part Number: 73-0510; GTIN: 07613327050301 Lot Numbers: 57A2, 3WP6, E10K, X49N, WJ3L, 38TY,76 units US;
Z-0888-2024SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-0710; GTIN: 07613327050295 Lot Numbers: RLAR, 2P84, EW6V, 90AV, 4JHN, 65A3, 22MP, NNE7, Y373, 58LA, VXAL, 4201, A2AN, 5YP8, X0P9, 9A8T,6LN7, WEL3, NDK3, 25WJ, T2JW, YVWT, 7DR0, DMVL,269 units US; 307 units OUS
Z-0889-2024SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910; GTIN: 07613327050332 Lot Numbers: X1WP, 6KE9, DL4V, HHPW, 1NL2, 4JHW, 0TNX, WN5E, 2EM2, 96N0, HW7E,T9NM, J72T, M73H, HM8H, MEM7, M8HN, WL3Y192 units US
Z-0890-2024SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-2110; GTIN: 07613327033816 Lot Numbers: LT28, 4TXX4 units
Z-0891-2024SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710; GTIN: 07613327033847 Lot Numbers: V25H, MD9E, 5MYL, H9T8, 845P,36 units US
Z-0892-2024SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910; GTIN: 07613327033854 Lot Numbers: A02W, NPPV, 75TX, 6RLN16 units US; 56 units OUS
Z-0893-2024SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3110; GTIN: 07613327033861 Lot Numbers: XEA7, 8P83, 690Y, MRM3, 67D4, 4902, YNP7, 3AYN, AYHM, W3MD, 76KN, K4P9, 792H, 43T8, MW40107 units US; 176 units OUS
Z-0894-2024SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3308; GTIN: 07613327033878 Lot Numbers: 2H58, 2J0W, 8H52, 64MJ, X0H9, 70E91 units US; 146 units oUS
Z-0895-2024SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508; GTIN: 07613327033885 Lot Numbers: EPXH, DYAE, XVK2, PVP9, LJ0K, 12R3, N8P6, T355, 8HDN, A3EV, 5LKW, R04Y, RKT1,D06K, 01JR, 3PA4, 0AYL, W424, 53T1, Y7X2,137 units US; 326 units OUS
Z-0896-2024SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3708; GTIN: 07613327033892 Lot Numbers: RDWN, 4W3T, V768, VJ05, TWT6, ADK0, 855, D6D9, TXL1, 53RN, KR24, M3T4, VE90, EKK2, 36L1, NH6E, 8PWK, R9A4, NWXA, D47L, 5JVL, D16P, E2LP, 927H, JR5N149 units US; 424 units OUS
Z-0897-2024SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710; GTIN: 07613327033908 Lot Numbers: RNT5, 3YNP, PEA1, NNA5, 5A2R, 98AH, T1JH, 8D72, E0VH, 3PA0, 05L4, R608118 units US; 212 units OUS
Z-0898-2024SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910; GTIN: 07613327033915 Lot Numbers: 73JP, V17W, N2MY, PK0D, D3M3, LEAY, 4NTR,R5WA, JN8M, 084W, K6YE, 84A4, XREK, YNM1, LY5M, M1AT, 4873143 units US; 290 units OUS
Z-0899-2024Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908; GTIN: 04546540400734 Lot Numbers: 42874701, 42912101, 42995601—
Z-0900-2024Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910; GTIN: 04546540400741 Lot Numbers: 42912201,429619014 units US
Z-0901-2024HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-28J; GTIN: n/a Lot Numbers: 38059601—
Z-0902-2024HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J; GTIN: n/a Lot Numbers: 29518001—
Z-0903-2024HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J; GTIN: n/a Lot Numbers: 29518001—
Z-0904-2024P7 28MM 10 DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-107; GTIN: 07613153076155 Lot Numbers: 61311701, 62122001—
Z-0905-2024P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307; GTIN: 07613153076407 Lot Numbers: 62112001,62120801—
Z-0906-2024LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028; GTIN: 04546540305831 Lot Numbers: 42771401—
Z-0907-2024LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-228; GTIN: 04546540306012 Lot Numbers: 54537601—
Z-0908-2024LEFT LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-231; GTIN: 04546540306029 Lot Numbers: 42787901—
Z-0909-2024LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328; GTIN: 04546540306104 Lot Numbers: 42579701—
Z-0910-2024LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631; GTIN: 04546540306203 Lot Numbers: 36272501,42380501 42771601—
Z-0911-2024RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831; GTIN: 04546540306388 Lot Numbers: 47475901—
Z-0912-2024RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928; GTIN: 04546540306463 Lot Numbers: 41875401—
Z-0913-2024RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931; GTIN: 04546540306470 Lot Numbers: 57403601—
Z-0914-2024PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031; GTIN: 04546540306920 Lot Numbers: 36273601, 36609701—
Z-0915-2024LARGE PRIMARY REV.TIB.INSERT- DURACON Intended for knee replacement Product Number: 6637-4-231; GTIN: 04546540307101 Lot Numbers: 33164901—
Z-0916-2024DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709; GTIN: 04546540318145 Lot Numbers: 52098201, 54184201, 56002801, 50677001, 56662001—
Z-0917-2024DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911; GTIN:04546540318299 Lot Numbers: 56000801, 57491601—
Z-0918-2024DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200; GTIN: 04546540318398 Lot Numbers: 383541—
Z-0919-2024DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-609; GTIN: 04546540322876 Lot Numbers: 50884601—
Z-0920-2024DUR PCA MTK REV INS LFT Intended for knee replacement Product Number: 6728-2-611; GTIN: 04546540322883 Lot Numbers: 52814401—
Z-0921-2024DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-709; GTIN: 04546540322944 Lot Numbers: 51828501—
Z-0922-2024DUR PCA MTK REV INS RT Intended for knee replacement Product Number: 6728-2-711; GTIN: 04546540322951 Lot Numbers: 52177701—
Z-0923-2024PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411; GTIN: 04546540324108 Lot Numbers: 584223—
Z-0924-2024PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-413; GTIN: 04546540324115 Lot Numbers: 559469, 561926, 584958—
Z-0925-2024PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416; GTIN: 04546540324122 Lot Numbers: 571630, 582549, 584840—
Z-0926-2024TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324; GTIN: 04546540117144 Lot Numbers: 59065701—
Based on the official FDA remedy

What to do — step by step

  1. Check Implant Details

    Look for part number 72-16-0910 and lot numbers starting with 43103101 on the implant.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, UK, & Venlo (Netherlands). ***Updated 1/25/24*** Foreign distribution added:…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 1, 202312. FDA classified it Class II: Jan 31, 202423. Published in FDA’s Enforcement Report: Feb 7, 2024320232024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to do anything if my implant is less than 5 years old?

The recall specifies units over 5 years of age as potentially affected, so implants less than 5 years old are not included.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0885-2024 (December 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0885-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA