FDA Device recall Z-0811-2022
BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008
- FDA Device
- Class II
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class II recall of BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008 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-0811-2022 |
| 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 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.
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 | Lot # 913430, UDI:(01)00887868445897(17)310616(10)913430 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0811-2022%22
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