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U.S. Department of Health and Human Services

Class 2 Device Recall Short tibial bearing MK4

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  Class 2 Device Recall Short tibial bearing MK4 see related information
Date Initiated by Firm August 24, 2022
Date Posted September 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-1778-2022
Recall Event ID 90836
510(K)Number K140898  
Product Classification Prosthesis, knee, patello/femorotibial, constrained, cemented, polymer/metal/polymer - Product Code KRQ
Product Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
Code Information Lot number B24694 (no UDI)
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Keyla Colon
201-831-5000
Manufacturer Reason
for Recall		 A MK4 Tibial Bearing was supplied with the intention to mate with the Tibial Metal Casing in-situ. However, the device in-situ was a MK3 Tibial Metal Casing. The supplied MK4 tibial bearing was not exchangeable for the MK3 tibial bearing. The surgeon needed to complete the surgery by re-assembling and re-inserting the extracted MK3 tibial bearing.
FDA Determined
Cause 2		 Under Investigation by firm
Action On August 24, 2022, the firm sent written notification (Product Field Action) to the single affected customer to document the event. The customer was asked to confirm their receipt of the notice.
Quantity in Commerce 1 unit
Distribution Distributed to one customer located in New York.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KRQ and Original Applicant = STANMORE IMPLANTS WORLDWIDE LTD.
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