—#85397

Product

CuttingEdge Total Hip Instrumentation Surgical Protocol; Acetabular and Femoral Surgical Technique for Primary Press Fit and Cemented Hip Implants. Stryker Howmedica Osteonics. Surgical protocols instruct surgeons on proper surgical technique.

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: K022555
Affected lot / code info: Catalog Number/Code Number: LSP42.

Why it was recalled

Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone.

Root cause (FDA determination)

Error in labeling

Action the firm took

"Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747).

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2009-08-31
Posted by FDA: 2010-01-11
Terminated: 2013-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.