FDA Device recall Z-1357-2015
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation by Depuy Orthopaedics, citing this lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1357-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-23 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Depuy Orthopaedics |
| Distribution | US |
Product
RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instrument for hip implantation.
Reason
This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Identifiers
| code_info | CATALOG NO. : 2975-00-920: Barcode (GTIN): 10603295156192 Lot No. Distribution SO2018074 (Distributed) SO2018072…CATALOG NO. : 2975-00-920: Barcode (GTIN): 10603295156192 Lot No. Distribution SO2018074 (Distributed) SO2018072 (Not Distributed) SO2018073 (Not Distributed) SO2018075 (Not Distributed) SO2018080 (Not Distributed) |
|---|
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-1357-2015%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.