—#107786

Product

Osteonics Shoulder Glenoid Spanner Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Solar Upper Extremity System Hemi and Total Shoulder Arthroplasty system is designed to address the most common arthritic disorders affecting the shoulder. The spherical reamer is used to prepare the glenoid fossa and provide a uniform surface for instrumentation and implant placement. The glenoid fossa is then sized using surface templates to confirm the appropriate coverage, size and curvature has been determined. To achieve this in surgery, the spherical reamer (5900-2050/-2051/-2052/-2053) must be attached to the Angled Glenoid Driver (5900-2040) by threading the reamer's male threads into the driver's female threads. The spherical reamers come in sizes 5, 7, 9 & 11, each with a captive drill head screw (5900-2054/-2055). The spanner features two kidney shaped male lobes that mate with two similar kidney shaped female slots in the screw's head and is used to tighten and loosen the spherical reamers with the angled driver. These instruments are part of the Solar Total Shoulder Instrument set and can be found in Surgical Protocol LSPUE-4 dated 10/04. Each set contains one spanner that universally fits all size reamers.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Description: Glenoid Reamer Spanner Catalog Number: 5900-2056 Lot Code: F3W7017 510k Exempt

Why it was recalled

Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Stryker sent an "URGENT PRODUCT RECALL" letter dated December 21, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Product Recall Acknowledgment Form was attached for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-972-2100 for questions regarding this notice.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the country of Canada.

Timeline

Recall initiated: 2011-11-17
Posted by FDA: 2012-03-22
Terminated: 2012-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107786. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.