4 — Class II medical device recall Z-2060-2012
Terminated recall by Synthes USA HQ, Inc., reported 2012-08-01, distributed nationwide. Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
| Recall number | Z-2060-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2012-05-22 |
| Classified | 2012-07-23 |
| Reported by FDA | 2012-08-01 |
| Terminated | 2015-09-10 |
| Distributed | Nationwide (US) |
| Quantity | 20 |
| Reason classes | labeling |
| Lot numbers | 2721745 |
| Model numbers | 038S, 04.019, 04.019.028S |
| Expiration dates | 2012-04-29 |
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 for recall
Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2060-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.