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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 Connexionsee related information
Date Initiated by FirmJune 29, 2021
Date PostedJuly 22, 2021
Recall Status1 Open3, Classified
Recall NumberZ-2131-2021
Recall Event ID 88126
510(K)NumberK051556 K070479 K100269 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
ProductExactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 28mm; Novation GXL 10 Deg Liner, G0, 28mm; and Novation GXL Liner, 10 Deg Face, 28mm. Orthopedic hip implant component.
Code Information All serial numbers. UDI-DI numbers: 10885862024589, 10885862024596, 10885862024602, 10885862024619, 10885862024626, 10885862024633, 10885862024664, 10885862024671
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 Nw 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactMr. 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
ActionThe 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 Commerce89,050 total
DistributionDistribution US nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPH
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