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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer M/L Taper Hip Prosthesis

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  Class 2 Device Recall Zimmer M/L Taper Hip Prosthesis see related information
Date Initiated by Firm February 11, 2016
Create Date March 04, 2016
Recall Status1 Terminated 3 on December 01, 2016
Recall Number Z-1046-2016
Recall Event ID 73298
510(K)Number K032726  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Code Information Item: 00-7711-012-20, Lot: 62937093
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact Kevin W. Escapule
574-267-6131
Manufacturer Reason
for Recall		 Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.
FDA Determined
Cause 2		 Under Investigation by firm
Action Zimmer, Inc. initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Electronic notices were e-mailed to distributors, and letters were mailed via certified mail on 02/11/2016 to distributors and hospitals. A field complaint investigation confirmed that this single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended Offset, and the device is an extended offset stem. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Acknowledgement Form. Customers are asked to complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.
Quantity in Commerce 9 units
Distribution Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
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 = LPH and Original Applicant = ZIMMER, INC.
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