FDA Device recall Z-1696-2015
PRI Femoral Impactor Block for knee prosthesis surgery
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of PRI Femoral Impactor Block for knee prosthesis surgery by Zimmer, citing potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1696-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-30 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
PRI Femoral Impactor Block for knee prosthesis surgery. Orthopedic Manual Surgical Instrument
Reason
Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. Foreign material has been observed on the impactor block. This has the potential for a biological response.
Identifiers
| code_info | Item No. 00-5901-032-00 Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575…Item No. 00-5901-032-00 Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1696-2015%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.