Date Initiated by Firm |
December 02, 2016 |
Create Date |
January 12, 2017 |
Recall Status1 |
Terminated 3 on August 01, 2018 |
Recall Number |
Z-1020-2017 |
Recall Event ID |
75889 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
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 |
Code Information |
Catalog #5901-1038 |
Recalling Firm/ Manufacturer |
Stryker Howmedica Osteonics Corp. 325 Corporate Dr Mahwah NJ 07430-2006
|
For Additional Information Contact |
Mr. Michael Van Ryn 201-831-5000
|
Manufacturer Reason for Recall |
Reunion TSA Peg Alignment Sound broke during surgery.
|
FDA Determined Cause 2 |
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 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. |
Quantity in Commerce |
131 units |
Distribution |
Nationwide Distribution |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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