Z-0810-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 30, 2022
- Initiation Date
- February 14, 2022
- Termination Date
- September 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]