—#188107

Product

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-32-XX, Acumatch GXL 15 Degree Liner, 32mm; Novation GXL Liner, Lipped Ant, 32mm; and Novation GXL Liner, Lipped, 32mm. Orthopedic hip implant component.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051556, K070479, K121392
Affected lot / code info: All serial numbers. UDI-DI numbers: 10885862023247, 10885862023254, 10885862023261, 10885862023278, 10885862207029, 10885862023315, 10885862023322, 10885862023339, 10885862023346, 10885862303325, 10885862303417, 10885862303424, 10885862303431, 10885862303448

Why it was recalled

Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 Nw 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Distribution US nationwide.

Timeline

Recall initiated: 2021-06-29
Posted by FDA: 2021-07-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188107. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.