| Class 2 Device Recall Exactech Connexion | |
Date Initiated by Firm | June 29, 2021 |
Date Posted | July 22, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2116-2021 |
Recall Event ID |
88126 |
510(K)Number | K051556 K070479 |
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 130-28-XX, Acumatch GXL 0 Degree Liner, 28mm; Novation GXL Liner, Neutral, 28mm; and Novation GXL Neutral Liner, G0, 28mm ID. Orthopedic hip implant component. |
Code Information |
All serial numbers. UDI-DI numbers: 10885862021984, 10885862021991, 10885862022004, 10885862022011, 10885862022028, 10885862022035, 10885862022059, 10885862022066, 10885862022073
|
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
|
|
|
|