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Open, Classified

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.

FDA Recall Z-2116-2021 · Posted 2021-07-22

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.

K070479EXACTECH NOVATION CROWN CUP AND LINERSExactech, Inc. · 2007-03-15K051556ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENEExactech, Inc. · 2005-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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