FDA Device recall Z-0810-2022
BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item…
- FDA Device
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item… by Biomet, citing 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 surgi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0810-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-14 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Biomet |
| Distribution | 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 |
Product
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
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.
Identifiers
| code_info | 6 lots: Lot #, UDI - [101220, (01)00887868446191(17)310623(10)101220], [101340, (01)00887868446207(17)310625(10)10134…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] |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Biomet
- Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description: Intramedullary Bone Saw Blade Assembly 13mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description: Intramedullary Bone Saw Blade Assembly 12mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description: Intramedullary Bone Saw Blade Assembly 16mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description: Intramedullary Bone Saw Blade Assembly 15mm
FDA Device · Class II · 2026-08-12 · Biomet - Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description: Intramedullary Bone Saw Blade Assembly 14mm
FDA Device · Class II · 2026-08-12 · Biomet
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0810-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.