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Class 2 Device Recall Exactech Connexion |
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Date Initiated by Firm |
June 29, 2021 |
Date Posted |
July 22, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2131-2021 |
Recall Event ID |
88126 |
510(K)Number |
K051556 K070479 K100269
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Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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Product |
Exactech 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
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Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 Nw 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact |
Mr. Nicholas Bennett 800-392-2832
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = LPH and Original Applicant = EXACTECH, INC.
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