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Lower risk Medical device recall · FDA · Published May 15, 2024

American Contract Systems TOTAL KNEE Procedure Tray Recall: EO/ECH Residuals Risk

American Contract Systems recalls TOTAL KNEE Procedure Tray (Catalog ANTK12AF) due to excessive ethylene oxide/ethylene chlorohydrin residuals in cast padding, potentially causing tissue damage with prolonged use.

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

🇺🇸 FDA recall #Z-2275-2024Medical deviceAmerican Contract Systems ›
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Contact the company

Recalling firmAmerican Contract Systems Inc85 Shaffer Park Dr · Tiffin, OH 44883-9290
✎ GovInfoNow plain-language explainer

American Contract Systems is recalling TOTAL KNEE Procedure Tray (Catalog ANTK12AF) because ethylene oxide and ethylene chlorohydrin residues in the cast padding may cause tissue damage with long-term use. This affects medical devices used in orthopedic procedures. Read more at govinfonow.com/recall/55073-american-contract-systems-total-knee-procedure-tray-recall-eo-ech.

Source Summary by GovInfoNow · govinfonow.com/recall/55073-american-contract-systems-total-knee-procedure-tray-recall-eo-ech · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2275-2024

Cite this page

“American Contract Systems TOTAL KNEE Procedure Tray Recall: EO/ECH Residuals Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55073-american-contract-systems-total-knee-procedure-tray-recall-eo-ech. Based on FDA recall #Z-2275-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2275-2024%22&limit=1).

American Contract Systems Inc voluntarily recalled one procedure tray due to ethylene oxide residuals exceeding safety limits, according to the FDA on May 15, 2024.

How to tell if you have it

  • Brand: American Contract Systems
  • Product: TOTAL KNEE - 302497- Procedure tray
  • Catalog Number: ANTK12AF
  • UDI-DI: 00191072214553
  • Lot Numbers: 968241

The hazard

The cast padding component of the procedure tray contained ethylene oxide and ethylene chlorohydrin residuals that exceeded the limits for permanent exposure devices as indicated by ANSI/AAMI/ISO 10993-7/(R)2012.

Context

GovInfoNow's records show American Contract Systems Inc has 21 other recalls on record since November 21, 2018. Other recent recalls of similar products include Howmedica Osteonics Recalls Knee Implant Components Due to Oxidation Risk (July 30, 2026) and Howmedica SCORPIO C-DOME/PATELLA Implants Recall: Risk of Excessive Wear Debris (July 30, 2026).

How to tell if you have this one

Check for the catalog number ANTK12AF on the procedure tray. The device was sold with lot numbers starting with 968241. The UDI-DI code 00191072214553 identifies the specific batch.

  • Brand
    American Contract Systems
  • Category
    Medical device
FDA recall event · 39 products

All 39 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
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2274-2024AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K; UDI-DI: 00191072214126 LOT#"s: 638231 962241 898241345 units
Z-2275-2024TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF; UDI-DI: 00191072214553 LOT#"s: 96824166 units
Z-2276-2024MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B; UDI-DI: 00191072216885 LOT#"s: 94624126 units
Z-2277-2024LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X; UDI-DI: 00191072214553 LOT#"s: 94324148 units
Z-2278-2024TOTAL KNEE - 247546 - Procedure tray Catalog Number: BFTK01AA; UDI-DI: 00191072215970 LOT#"s: 922241N/A
Z-2279-2024TOTAL KNEE - 247546 Procedure tray Catalog Number: BFTK01Z; UDI-DI: 00191072214614 LOT#"s: 98324150 units
Z-2280-2024ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A; UDI-DI: 00191072187444 LOT#"s: 661231 971241 928241 89324196 units
Z-2281-2024ARTHROSCOPY SUP JOI PACK Procedure tray Catalog Number: BPAS17C; UDI-DI: 00191072197825 LOT#"s: 665231 950241272 units
Z-2282-2024ARTHO KNEE BAPTIST SOUTH PACK Procedure tray Catalog Number: BPKA49B; UDI-DI: 00191072197931 LOT#"s: 953241 882241129 units
Z-2283-2024ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B; UDI-DI: 00191072197948 LOT#"s: 992241 91424184 units
Z-2284-2024BPKN15C KNEE BASIN PACK BHS- Procedure tray Catalog Number: BPKN15C; UDI-DI: 00191072200518 LOT#"s: 639231 928241552 units
Z-2285-2024FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B; UDI-DI: 00191072193148 LOT#"s: 651231 983241 940241 901241107 units
Z-2286-2024HAND WRIST FOREARM-LF Procedure tray Catalog Number: CCHD17B; UDI-DI: 00191072193179 LOT#"s: 651231 94824148 units
Z-2287-2024KNEE SCOPE Procedure tray Catalog Number: COKN48L; UDI-DI: 00191072176301 LOT#"s: 644231 955241 91524136 units
Z-2288-2024UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG; UDI-DI:00191072207791 LOT#"s: 658231 953241 899241192 units
Z-2289-2024ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA; UDI-DI: 00191072209290 LOT#"s: 666231 9312418 units
Z-2290-2024TOTAL KNEE, ST LUKES Catalog Number: LMTK17AP; UDI-DI: 00191072192172 LOT#"s: 645231 976241 918241272 units
Z-2291-2024KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R; UDI-DI: 00191072174475 LOT#"s: 659231 97824184 units
Z-2292-2024KNEE ARTHROSCOPY-Procedure Kit Catalog Number: QPKA35A; UDI-DI: 00191072201119 LOT#"s: 91324136 units
Z-2293-2024TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A; UDI-DI: 00191072201225 LOT#"s: 968241 92224150 units
Z-2294-2024TOTAL KNEE -Procedure Kit Catalog Number: QPTK95B; UDI-DI: 00191072221063 LOT#"s: 91124126 units
Z-2295-2024HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I; UDI-DI: 00191072203175 LOT#"s: 646231 92724136 units
Z-2296-2024TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K; UDI-DI: 00191072203267 LOT#"s: 66523124 units
Z-2297-2024TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L; UDI-DI: 00191072216182 LOT#"s: 93924124 units
Z-2298-2024KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A; UDI-DI: 00191072167408 LOT#"s: 992241 954241270 units
Z-2299-2024TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B; UDI-DI: 00191072195999 LOT#"s: 680231 997241 969241 947241976 units
Z-2300-2024HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F; UDI-DI: 00191072192349 LOT#"s: 662231 981241 917241 882241352 units
Z-2301-2024KNEE ARTHROSCOPY-Procedure Kit Catalog Number: SLAR14G; UDI-DI: 00191072198563 LOT#"s: 975241 92024128 units
Z-2302-2024TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C; UDI-DI: 00191072203205 LOT#"s: 975241 956241 920241 90724185 units
Z-2303-2024ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22U; UDI-DI: 00191072199768 LOT#"s: 66523127 units
Z-2304-2024ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V; UDI-DI: 00191072212740 LOT#"s: 97824127 units
Z-2305-2024TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E; UDI-DI: 00191072171726 LOT#"s: 640231 973241 742231 934241393 units
Z-2306-2024ACL PACK - 206039-Procedure Kit Catalog Number: UDAC66AA; UDI-DI: 00191072216212 LOT#"s: 8962416 units
Z-2307-2024CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AE; UDI-DI: 00191072172532 LOT#"s: 651231174 units
Z-2308-2024CUSTOM KNEE - 206061-Procedure Kit Catalog Number: UDKN68AG; UDI-DI: 00191072216335 LOT#"s: 955241174 units
Z-2309-2024ORIF HIP - IM RODDING FEMUR-Procedure Kit Catalog Number: UTHP44S; UDI-DI: 00191072154934 LOT#"s: 639231 93624128 units
Z-2310-2024HAND PACK-Procedure Kit Catalog Number: WEHD16B; UDI-DI: 00191072188632 LOT#"s: 662231 983241 934241135 units
Z-2311-2024HAND PACK-Procedure Kit Catalog Number: WEHD16C; UDI-DI: 00191072217035 LOT#"s: 89424145 units
Z-2312-2024KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B; UDI-DI: 00191072199379 LOT#"s: 996241 96024160 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Details

    Identify the catalog number (ANKT12AF) and lot numbers starting with 968241 on the procedure tray.

Where it went and when

Where it was distributed

Distributed nationwide.

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: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

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

1. Firm started the recall: May 15, 202412. FDA classified it Class II: Jul 5, 202423. Published in FDA’s Enforcement Report: Jul 17, 202432024
  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.

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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-2275-2024 (May 15, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2275-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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