Stryker Orthopaedics Torx 6 — Class II medical device recall Z-0387-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2012-11-28, distributed nationwide. Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are e
| Recall number | Z-0387-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2012-08-17 |
| Classified | 2012-11-19 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2014-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CA, DE, ES, FI, GB, GR, HK, IE, IT, JP, PL, PT, TR |
| Quantity | 72 units |
| Lot numbers | MLHYL7, MLJT50 |
| Model numbers | 2030-6525-1, 6.5MM |
Product
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
Reason for recall
Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
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-0387-2013. 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.