Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Most Hinged Tibia Baseplate Spacer

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Zimmer Most Hinged Tibia Baseplate Spacersee related information
Date Initiated by FirmJanuary 29, 2009
Date PostedMarch 09, 2009
Recall Status1 Terminated 3 on November 12, 2009
Recall NumberZ-0996-2009
Recall Event ID 51039
510(K)NumberK013031 
Product Classification Knee Femorotibial Metal/Polymer Constrained Cemented Prosthesis - Product Code KRO
ProductZimmer 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
ActionThe 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 Commerce3
DistributionInternational Distribution only -- Country of Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = KRO
-
-