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Use caution Medical device recall · FDA · Published February 14, 2022

Biomet Trauma A.L.P.S. Fibula Plate Recall: Infection Risk from Packaging

Biomet recalls specific fibula plates due to potential packaging failure causing infection risks during surgery. Affected items have item # 856204008 and lot # 913430. Contact for replacement or return.

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

🇺🇸 FDA recall #Z-0811-2022Medical deviceBiomet ›
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Contact the company

Recalling firmBiomet, Inc.56 E Bell Dr · Warsaw, IN 46582-6989
✎ GovInfoNow plain-language explainer

Biomet is recalling a specific type of fibula plate used in trauma surgery because its packaging might not seal properly, increasing infection risk during surgery. This could require additional surgery or longer procedures to find the correct implant. Read more at govinfonow.com/recall/61147-biomet-trauma-a-l-p-s-fibula-plate-recall-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/61147-biomet-trauma-a-l-p-s-fibula-plate-recall-infection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0811-2022

Cite this page

“Biomet Trauma A.L.P.S. Fibula Plate Recall: Infection Risk from Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61147-biomet-trauma-a-l-p-s-fibula-plate-recall-infection. Based on FDA recall #Z-0811-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0811-2022%22&limit=1).

The FDA announced on Feb. 14, 2022, that Biomet, Inc. is recalling the BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE due to potential loss of sterile barrier integrity. The agency said the defect poses a risk of infection and may require surgical intervention. Owners should contact Biomet for a replacement.

How to tell if you have it

  • Brand: Biomet
  • Product: BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE
  • Item #: 856204008
  • UPC: 00887868445897
  • Lot #: 913430
  • UDI: (01)00887868445897(17)310616(10)913430
  • Quantity: 12 units
  • Distribution: US (AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, Netherlands

The hazard

The packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity, according to the FDA. Use of the product poses a risk of infection, which could lead to surgical intervention and/or extension of surgery to find another part.

Context

GovInfoNow's records show Biomet, Inc. has had 28 other recalls on record since Feb. 28, 2018. Other recent recalls include the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026), the Biomet ZipT recall (Sept. 23, 2025), and the Biomet Juggerknot Mini Soft Anchors Recall (Sept. 9, 2025). Other recent recalls of similar products include the Medline Convenience Kits Recall (June 12, 2026) and the Medline Forceps Recall (Nov. 13, 2025).

How to tell if you have this one

Check for item number 856204008 on the packaging and lot number 913430 on the label. The product comes in a vacuum-sealed nylon pouch inside a carton with patient record labels.

  • Brand
    Biomet
  • Product
    BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed
  • Category
    Medical device
FDA recall event · 4 products

All 4 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
    Terminated
  • Distribution
    Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands
Recall numberProduct, codes & lotsQuantity
Z-0809-2022BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.; 29 lots: Lot Number, UDI Number - [061400, (01)00887868465758(17)310630(10)061400], [061410, (01)00887868465758(17)310723(10)061410], [089370, (01)00887868465758(17)310726(10)089370], [260770, (01)00880304857261(17)310917(10)260770], [503410, (01)00880304857285(17)311011(10)503410], [503420, (01)00880304857261(17)310924(10)503420], [503430, (01)00880304857285(17)311011(10)503430], [503450, (01)00880304857261(17)310924(10)503450], [503460, (01)00880304857285(17)311011(10)503460], [503610, (01)00880304857285(17)310924(10)503610], [539370, (01)00880304857285(17)311105(10)539370], [549910, (01)00887868465758(17)310603(10)549910], [577830, (01)00880304857292(17)310917(10)577830], [577840, (01)00880304857292(17)310922(10)577840], [577860, (01)00880304857292(17)310917(10)577860], [637200, (01)00880304857285(17)311027(10)637200], [796600, (01)00880304857285(17)311105(10)796600], [796610, (01)00880304857261(17)311027(10)796610], [886120, (01)00880304857285(17)310805(10)886120], [886200, (01)00880304857285(17)310805(10)886200], [886210, (01)00880304857285(17)310727(10)886210], [886220, (01)00880304857285(17)310726(10)886220], [886230, (01)00880304857285(17)310813(10)886230], [886240, (01)00880304857285(17)310805(10)886240], [886260, (01)00880304857285(17)310922(10)886260], [886270, (01)00880304857285(17)310922(10)886270], [886290, (01)00880304857285(17)310917(10)886290], [954740, (01)00880304857285(17)310922(10)954740], [954760, (01)00880304857285(17)310922(10)954760]702
Z-0810-2022BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.; 6 lots: Lot #, UDI - [101220, (01)00887868446191(17)310623(10)101220], [101340, (01)00887868446207(17)310625(10)101340], [101450, (01)00887868446313(17)310630(10)101450], [101560, (01)00887868446191(17)310624(10)101560], [119180, (01)00887868446313(17)310630(10)119180], [154060, (01)00887868446313(17)310630(10)154060]38
Z-0811-2022BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.; Lot # 913430, UDI:(01)00887868445897(17)310616(10)91343012
Z-0812-2022BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill Bit, Item # 829032170, 3.5X140MM DRILL], [ALPS Tap, Item # 824150170, 3.5X140MM CORTICAL TAP], [ALPS Guide Pin, Item # 829516150, 1.6X150MM BAYONET TIP GUIDE PIN], [ALPS Guide Pin, Item # 829516151, 1.6X150MM THREADED TIP GUIDE PIN]. Instruments are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.; 44 lots: Lot #, UDI # - [014490, (01)00887868447037(17)310608(10)014490], [014500, (01)00887868447068(17)310608(10)014500], [014520, (01)00887868447068(17)310610(10)014520], [084850, (01)00887868447006(17)310621(10)084850], [084860, (01)00887868447006(17)310623(10)084860], [084870, (01)00887868447006(17)310623(10)084870], [084880, (01)00887868447006(17)310624(10)084880], [102920, (01)00887868447006(17)310630(10)102920], [102930, (01)00887868447006(17)310716(10)102930], [102940, (01)00887868447006(17)310729(10)102940], [102950, (01)00887868447006(17)310729(10)102950], [102960, (01)00887868447006(17)310728(10)102960], [103120, (01)00887868447006(17)310728(10)103120], [119750, (01)00887868446054(17)310624(10)119750], [119760, (01)00887868446054(17)310624(10)119760], [120800, (01)00887868446054(17)310630(10)120800], [120810, (01)00887868446054(17)310713(10)120810], [204700, (01)00887868447006(17)310714(10)204700], [205750, (01)00887868447006(17)310714(10)205750], [331580, (01)00887868446054(17)310803(10)331580], [331590, (01)00887868446054(17)310723(10)331590], [331600, (01)00887868446054(17)310726(10)331600], [386440, (01)00887868447105(17)310809(10)386440], [391450, (01)00887868446054(17)310816(10)391450], [391470, (01)00887868447068(17)310811(10)391470], [391660, (01)00887868447068(17)310811(10)391660], [391670, (01)00887868447075(17)310811(10)391670], [416500, (01)00887868446054(17)310817(10)416500], [416510, (01)00887868446054(17)310817(10)416510], [416520, (01)00887868446054(17)310819(10)416520], [416640, (01)00887868446054(17)310823(10)416640], [492660, (01)00887868447006(17)310722(10)492660], [534680, (01)00887868446948(17)310713(10)534680], [534690, (01)00887868446948(17)310713(10)534690], [534700, (01)00887868446948(17)310812(10)534700], [610840, (01)00887868446948(17)310915(10)610840], [806490, (01)00887868447075(17)310528(10)806490], [820340, (01)00887868447006(17)310618(10)820340], [834950, (01)00887868446733(17)311101(10)834950], [836360, (01)00887868446948(17)310119(10)836360], [896640, (01)00887868446733(17)311101(10)896640], [896660, (01)00887868446733(17)311027(10)896660], [939270, (01)00887868447068(17)310601(10)939270], [964360, (01)00887868447068(17)310603(10)964360]2594
Based on the official FDA remedy

What to do — step by step

  1. Check Packaging Labels

    Look for item number 856204008 and lot number 913430 on the vacuum-sealed pouch and carton.

Where it went and when

Where it was distributed

Distributed in 28 states, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: not listedMAOregon: yesORNevada: not listedNVWyoming: yesWYSouth Dakota: not listedSDIowa: not listedIAIndiana: yesINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: not listedMOKentucky: yesKYWest Virginia: not listedWVVirginia: not listedVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Nebraska, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Washington, Wyoming.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Feb 14, 202212. FDA classified it Class II: Mar 18, 202223. Published in FDA’s Enforcement Report: Mar 30, 202234. FDA terminated the recall: Sep 30, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0811-2022 (February 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0811-2022 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