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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics

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  Class 2 Device Recall Stryker Orthopaedics see related information
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
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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