Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp — Class II medical device recall Z-0483-2014

Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-12-18, distributed nationwide. Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified i

Recall number	`Z-0483-2014`
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	2013-10-01
Classified	2013-12-11
Reported by FDA	2013-12-18
Terminated	2015-07-15
Distributed	Nationwide (US)
Lot numbers	`MMLMJ1`
Model numbers	`2029-5540-1`, `2030-6525-1`

Product

Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.

Reason for recall

Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.

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-0483-2014. 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.