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U.S. Department of Health and Human Services

Class 2 Device Recall Exactech Connexion

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  Class 2 Device Recall Exactech Connexion see related information
Date Initiated by Firm June 29, 2021
Create Date July 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-2117-2021
Recall Event ID 88126
510(K)Number K051556  K070479  K121392  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; and Novation GXL Liner, Neutral, 32mm. Orthopedic hip implant component.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Mr. Nicholas Bennett
800-392-2832
Manufacturer Reason
for Recall
Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products.
Quantity in Commerce 89,050 total
Distribution Distribution US nationwide.
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 = LPH and Original Applicant = EXACTECH, INC.
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