Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. Orthopedic hip implant component.
FDA Recall Z-2119-2021 · Posted 2021-07-22
Advertisement
Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2021-06-29
Product Quantity89,050 total
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.
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Distribution US nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement