Z-0810-2022 Class II Terminated
FDA device recall Z-0810-2022 was initiated by Biomet, Inc. on Feb 14, 2022 and is designated Class II. 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… The recall status is terminated (terminated Sep 30, 2024). Affected quantity: 38.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 30, 2022
- Initiation Date
- Feb 14, 2022
- Termination Date
- Sep 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38
Product Description
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.
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.
Distribution Pattern
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
Code Information
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]
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0810-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026