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U.S. Department of Health and Human Services

Class 2 Device Recall Trauma Tubes and Plates

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  Class 2 Device Recall Trauma Tubes and Plates see related information
Date Initiated by Firm July 22, 2014
Date Posted August 26, 2014
Recall Status1 Terminated 3 on September 15, 2015
Recall Number Z-2550-2014
Recall Event ID 68818
510(K)Number K830196  
Product Classification Plate, fixation, bone - Product Code HRS
Product Trauma Tubes and Plates:
TUBE & SCP PLT 90DX150LG
TUBE & SCP PLT 90DX205LG
TUBE & SCP PLT 90DX255LG
TUBE & SCP PLT 95DX150LG
TUBE & SCP PLT 95DX205LG
TUBE & SCP PLT 95DX255LG
TUBE&SCP PLT 130DX8H
TUBE&SCP PLT 130DX10H
TUBE&SCP PLT 130DX12H
TUBE&SCP PLT 130DX14H
TUBE&SCP PLT 135DX8H
TUBE&SCP PLT 135DX10H
TUBE&SCP PLT 135DX12H
TUBE&SCP PLT 135DX14H
TUBE&SCP PLT 140DX8H
TUBE&SCP PLT 140DX10H
TUBE&SCP PLT 140DX12H
TUBE&SCP PLT 140DX14H
TUBE&SCP PLT 145DX8H
TUBE&SCP PLT 145DX10H
TUBE&SCP PLT 145DX12H
TUBE&SCP PLT 145DX14H
TUBE&SCP PLT 150DX6H
TUBE&SCP PLT 150DX8H
TUBE&SCP PLT 150DX10H
TUBE&SCP PLT 150DX12H
TUBE&SCP PLT 150DX14H
VERSA-FX II SC TUBE PLT 90DX6H
VERSA-FX II SC TUBE PLT 90DX8H
VERSA-FXII SC TUBE PLT 90DX10H
VERSA-FXII SC TUBE PLT 90DX12H
VERSA-FXII SC TUBE PLT 90DX14H
VERSA-FXII SC TUBE PLT 95DX6H
VERSA-FXII SC TUBE PLT 95DX8H
VERSA-FXII SC TUBE PLT 95DX10H
VERSA-FXII SC TUBE PLT 95DX12H
VERSA-FXII SC TUBE PLT 95DX14H
VERSA-FX KEYLESS 90D X 8HOLE
VERSA-FX KEYLESS 90D X 11HOLE
VERSA-FX KEYLESS 95D X 8HOLE
VERSA-FX KEYLESS 95D X 11HOLE
VERSA-FX KEYLESS 95D X 14HOLE
VERSA-FX II STD TUBE 130DX8H
VERSA-FX II STD TUBE 130DX10H
VERSA-FX II STD TUBE 130DX12H
VERSA-FX II STD TUBE 130DX14H
VERSA-FX II STD TUBE 135DX8H
VERSA-FX II STD TUBE 135DX10H
VERSA-FX II STD TUBE 135DX12H
VERSA-FX II STD TUBE 135DX14H
VERSA-FX II STD TUBE 140DX8H
VERSA-FX II STD TUBE 140DX10H
VERSA-FX II STD TUBE 140DX12H
VERSA-FX II STD TUBE 140DX14H
VERSA-FX II STD TUBE 145DX8H
VERSA-FX II STD TUBE 145DX10H
VERSA-FX II STD TUBE 145DX12H
VERSA-FX II STD TUBE 145DX14H
VERSA-FX II STD TUBE 150DX8H
VERSA-FX II STD TUBE 150DX10H
VERSA-FX II STD TUBE 150DX12H
VERSA-FX II STD TUBE 150DX14H
VERSA-FX II KEYLESS TB 130DX8H
VERSA-FX II KEYLESS TB 135DX8H
VERSA-FX II KEYLESS TB 140DX8H
VERSA-FX II KEYLESS TB 145DX8H
VERSA-FX II KEYLESS TB 150DX8H
VERSA-FX KEYLESS 90D X 8HOLE
VERSA-FX KEYLESS 90D X 11HOLE
VERSA-FX KEYLESS 95D X 8HOLE
VERSA-FX KEYLESS 95D X 11HOLE
VERSA-FX KEYLESS 95D X 14HOLE
Code Information Item Numbers: 00118109006, 00118109008, 00118109010, 00118109506, 00118109508, 00118109510, 00118113008, 00118113010, 00118113012, 00118113014, 00118113508, 00118113510, 00118113512, 00118113514, 00118114008, 00118114010, 00118114012, 00118114014, 00118114508, 00118114510, 00118114512, 00118114514, 00118115006, 00118115008, 00118115010, 00118115012, 00118115014, 00119309006, 00119309008, 00119309010, 00119309012, 00119309014, 00119309506, 00119309508, 00119309510, 00119309512, 00119309514, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514, 00119313008, 00119313010, 00119313012, 00119313014, 00119313508, 00119313510, 00119313512, 00119313514, 00119314008, 00119314010, 00119314012, 00119314014, 00119314508, 00119314510, 00119314512, 00119314514, 00119315008, 00119315010, 00119315012, 00119315014, 00119413008, 00119413508, 00119414008, 00119414508, 00119415008, 00119809008, 00119809011, 00119809508, 00119809511, 00119809514      EXPIRATION DATE PRIOR TO 2024-07
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
800-613-6131
Manufacturer Reason
for Recall		 Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
FDA Determined
Cause 2		 Package design/selection
Action Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Please call the Customer Call Center at 1-800-348-2759 for questions or concerns involving this notice.
Quantity in Commerce 972,125 units
Distribution Worldwide 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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ZIMMER, INC.
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