Recall Z-1276-2012 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
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 gleno
| Date | Mar 22, 2012 (initiated Nov 17, 2011) |
| Status | Terminated |
| Reason | Two product complaints reported that the Glenoid Reamer Spanner (Lot F3W7017) would not properly connect to the Glenoid Spherical Reamer. |
| Root cause | 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 | five units |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.