Recall Z-1020-2017 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Gle
| Date | Dec 2, 2016 |
| Status | Terminated |
| Reason | Reunion TSA Peg Alignment Sound broke during surgery. |
| Root cause | Device Design |
| Action | Stryker Orthopaedics sent an Urgent Medical Device Recall Notification letter dated December 2, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available to: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431 1360184/RA2016-112 Complete and sign |
| Quantity | 131 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.