—#151592

Product

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 Glenoid implant have been properly prepared using the provided instrumentation

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog #5901-1038

Why it was recalled

Reunion TSA Peg Alignment Sound broke during surgery.

Root cause (FDA determination)

Device Design

Action the firm took

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 the enclosed Business Reply Form and fax a copy to 855-261-3635 or email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com. Customers with questions were instructed to call 201-831-6693.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2016-12-02
Terminated: 2018-08-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #151592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.