INTERNAL HEX RECON SCREW — Class II medical device recall Z-0944-2013
Terminated recall by Smith & Nephew Inc, reported 2013-03-20, distributed in CA, HI, KY, MA, MI, NC, NJ, NM…. 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packa
| Recall number | Z-0944-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smith & Nephew Inc, Memphis, TN, United States |
| Recall initiated | 2013-02-07 |
| Classified | 2013-03-13 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2016-01-11 |
| Distributed | CA, HI, KY, MA, MI, NC, NJ, NM, OH, TN, TX |
| Countries outside the US | AE, AR, CA, CL, JP, MX |
| Quantity | 90 units |
| Reason classes | labeling |
| Lot numbers | 12JM17051 |
| Model numbers | 7162375 |
Product
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Reason for recall
75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
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-0944-2013. 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.