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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech BIOLOX delta Femoral Head

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  Class 2 Device Recall Exactech BIOLOX delta Femoral Head see related information
Date Initiated by Firm June 29, 2021
Create Date August 12, 2021
Recall Status1 Open3, Classified
Recall Number Z-2250-2021
Recall Event ID 88259
510(K)Number K050398  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Code Information Serial Numbers: 6465589-6465618; 6465641 
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall
Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 10-36-03 (36mm +3.5).
FDA Determined
Cause 2
Under Investigation by firm
Action The firm notified their direct consignees on 06/29/2021 by email. The letter requested return of the affected devices. The firm will issue a letter through the sales representatives to the implanting physicians to follow-up with the patients beginning 07/23/2021.
Quantity in Commerce 29 devices
Distribution US Nationwide 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 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 = LZO and Original Applicant = EXACTECH, INC.
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