FDA Device recall Z-2060-2012
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthe…
- FDA Device
- Class II
- terminated
- Published 2012-08-01
On 2012-08-01 the FDA classified a Class II recall of 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthe… by Synthes Usa Hq, citing two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2060-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-22 |
| Published | 2012-08-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
Product
4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a Multiloc PHN for treatment of proximal humerus fractures and is intended to be inserted through the Multiloc PHN until it engages the subchondral bone below the relative distal cortex (cortex closest to the humeral head, below the articular surface).
Reason
Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Identifiers
| code_info | Lot #2721745 Expiration 4/29/2012 REF 04.019.028S |
|---|
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-2060-2012%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.