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U.S. Department of Health and Human Services

Class 2 Device Recall Osteonics Shoulder Glenoid Spanner

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 Class 2 Recall
Osteonics Shoulder Glenoid Spanner
see related information
Date Posted March 22, 2012
Recall Status1 Terminated on December 19, 2012
Recall Number Z-1276-2012
Recall Event ID 61312
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
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.
Code Information Description: Glenoid Reamer Spanner Catalog Number: 5900-2056 Lot Code: F3W7017 510k Exempt
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, New Jersey 07430
For Additional Information Contact Ms. Colleen O'Meara
201-831-5970
Manufacturer Reason
for Recall
Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action 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.
Quantity in Commerce five units
Distribution Worldwide Distribution-USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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