—#108777

Product

Cutting Edge Acetabular Spherical Reamer 44 M, Stryker Howmedica Osteonics Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA. The CuttingEdge acetabular reamers are used to ream the acetabulum and prepare the bone for the insertion of the shell during hip arthroplasty. Surgical procedures for shells used with CuttingEdge instruments indicate that reaming should begin with a Spherical Reamer that is 4mm smaller than the templated or gauged size of the planned shell. Per the procedures, reaming should increase in size by 1mm increments until final sizing is achieved. Surgical judgment is used to assess bone stock, bone quality, desired level of press fit, and proper amount of reaming.

FDA product code: HTO — Reamer
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number 2102-0444 Lot number V2010068 No 510 K number No expiration date

Why it was recalled

A 46mm acetabular reamer was lasermarked as a 44m reamer and distributed to the field.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker sent an "URGENT PRODUCT RECALL" letter dated December 29, 2011 to all affected customers. Notification letters and Product Accountability Forms were sent to Stryker accounts via FedEx on January 3, 2012 with return receipt. Hospital Risk Management and Chief of Orthopaedics Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Surgeon Notification letters and Product Recall Acknowledgement Forms were sent on January 10, 2012. Notification sent via e-mail toCanada.EMEA, LatinAmerica.Asia Pacific on December 23, 2011. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to return the affected product. A Product Recall Acknowledgment Form was attached to the letter for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2011-12-23
Posted by FDA: 2012-05-17
Terminated: 2013-07-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #108777. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.