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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Most Hinged Tibia Baseplate Spacer

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  Class 2 Device Recall Zimmer Most Hinged Tibia Baseplate Spacer see related information
Date Initiated by Firm January 29, 2009
Date Posted March 09, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall Number Z-0996-2009
Recall Event ID 51039
510(K)Number K013031  
Product Classification Knee Femorotibial Metal/Polymer Constrained Cemented Prosthesis - Product Code KRO
Product Zimmer Most Hinged Tibia Baseplate Spacer, size 1, 6 mm, sterile, Zimmer, Warsaw, IN; REF 5020-06-001.

Component used to augment uni- and bi-compartmental defects and is manufactured from Ti-6A1-4V Alloy.
Code Information Lot 1635572.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 The package contains 11 mm screws instead of the specified 6 mm screws.
FDA Determined
Cause 2		 Packaging process control
Action The consignee in Germany was notified by an Urgent: Device Recall letter dated 1/29/09, and delivered by email on 2/19/09. The letter stated the reason for the recall and clinical implications. The firm asked the consignee to stop using the provisional and quarantine it immediately; physically count all affected product and record data on the Inventory Return Certification Form included with letter; fax a copy of the completed form to Zimmer, Inc at 574-371-8603; request an IRA from Lindsey Arnett; and return recalled product along with completed Inventory Return Certification Form and IRA to Simmer Distribution Center. The letter states that credit will be issued upon receipt of the returned product. Also, if product has been further distributed, a copy of the recall letter should be provided to the customers. Questions or assistance should be directed to Zimmer, Inc at 1-800-613-6131.
Quantity in Commerce 3
Distribution International Distribution only -- Country of Germany.
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.
510(K) Database 510(K)s with Product Code = KRO and Original Applicant = SULZER ORTHOPEDICS, INC.
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