Biomet, Inc. Recall 89701
Description: 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.
Biomet, Inc. Recall 89701 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0811-2022 |
| Event ID | 89701 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | 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 |
| Quantity | 12 |
| Recall 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. |
| Device Classification | 20220330 |
| Device Code Info | Lot # 913430, UDI:(01)00887868445897(17)310616(10)913430 |
| Center Classification Date | 20220318 |
| Recall Initiation Date | 20220214 |
| Recalling Firm | Biomet, Inc. |
| Initial Notification | Letter |
| Similar To |