CLASS II Device recall · Reported 30 Mar 2022 · FDA Enforcement Report
Biomet Trauma, [Item # 13182-22-26, DVR Crosslock Extra Long Plate recalled
Biomet is recalling Biomet Trauma, [, distributed in 28 states. The recall was initiated on 14 Feb 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0810-2022
- FDA event ID
- 89701
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Feb 2022
- FDA classified
- 18 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 14 Feb 2022 | Recall initiated by company | |
| 18 Mar 2022 | Classified by FDA | +32 days |
| 30 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
BIOMET 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.
Where it was distributed
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
AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIdahoIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMississippiNorth CarolinaNebraskaNew MexicoNew York
Questions about this recall
Is Biomet Trauma, [Item # 13182-22-26, DVR Crosslock Extra Long Plate recalled?
Yes. Biomet recalled Biomet Trauma, [Item # 13182-22-26, DVR Crosslock Extra Long Plate on 14 Feb 2022. The recall is Class II and its status is Terminated. Recall number Z-0810-2022.
Why was it recalled?
Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.
Which lots are affected?
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]
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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