FDA Device recall Z-1574-2016
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile by Synthes Usa Products, citing this lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct ex….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1574-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-04 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | IL, IN |
Product
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
Reason
This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date.
Identifiers
| code_info | Lot Number 5539094, Catalog ID # 02.221.462S Manufacture date 07/02/2007 Expiration date 05/31/2012 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1574-2016%22
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