Countersink
FDA product code HWW · Class I (low risk) · 21 CFR 888.4540 · Orthopedic
0510(k) clearances
0PMA approvals
17recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1488-2019 Class II | CBS high, countersink, cannulated, AO, Item Number ST503004542An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1487-2019 Class II | CBS micro, countersink, cannulated, AO, Item Number ST503004541An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1467-2019 Class II | V-TEK", Micro-countersink, AO , Item Number ST28.66.113An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1466-2019 Class II | V-TEK", standard-countersink, cannulated, AO, Item Number ST28.66.111An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1465-2019 Class II | V-TEK", Micro-countersink, AO, Item Number 28.66.113An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1464-2019 Class II | V-TEK", micro-countersink, round shaft, Item Number 28.66.112An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1463-2019 Class II | V-TEK", standard-countersink, cannulated, AO, Item Number 28.66.111An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1462-2019 Class II | V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1461-2019 Class II | CBS high, countersink, cannulated, AO, Item Number 503004542An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1460-2019 Class II | CBS micro, countersink, cannulated, AO, Item Number 503004541An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1459-2019 Class II | CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1458-2019 Class II | CBS 4.0 countersink, cannulated, 15mm stop, AO, Item Number 503004352An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1457-2019 Class II | CBS 4.5 countersink, cannulated, 18mm stop, round-shaft, Item Number 503004351An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1456-2019 Class II | CBS high, countersink, cannulated, round-shaft, Item Number 503004342An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1455-2019 Class II | CBS micro, countersink, cannulated, round-shaft, Item Number 503004341An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1454-2019 Class II | MaxiCan 4.5 countersink, cannulated, AO, Item Number 503004177An investigation identified that the products were possibly manufactured from a different material than… | Zimmer GmbH | 04/08/2019Terminated |
| Z-1934-2012 Class II | S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C Revision Instruments…Aesculap Implant Systems, LLC has initiated a voluntary removal of the S4 Cervical (S4C) Occiput Revision… | Aesculap Implant Systems LLC | 03/07/2012Terminated |