—#75529

Product

Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill County Cork, Ireland. Authorized Representative in Europe: Stryker France, Cedex France. This system is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of servere proximal bone loss.

FDA product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K022549
Affected lot / code info: Catalog No. 6276-7-017 (17mm), Lot Code CAXHA68D; Catalog No. 6276-7-014, (14mm) Lot Code CAXHB18A

Why it was recalled

Stryker became aware of a lot for lot mix up.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Recall notification letters sent via Federal Express on Nov. 21, 2008 to Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeons. Letters explain the labeling mix up and the potential risks to patients if the wrong size stem is used. Stryker branches are asked to examine inventory and that of hospital locations to identify affected product. All affected product is to be reconciled on the Product Accountability form and the form faxed back to Stryker. Contact Stryker Howmedical Osteonics Corporation for additional information at 1-201-831-5718.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Class II Recall - Nationwide Distribution

Timeline

Recall initiated: 2008-11-21
Posted by FDA: 2009-01-26
Terminated: 2012-06-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #75529. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.