Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm. Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-36-XX, Acumatch GXL 15 Degree, +5 Lat Liner, 36mm, Novation GXL Liner, 10 Deg Face, 36mm. (note: inadvertently left out of original posting) Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-40-XX, Novation GXL Liner, 10 Deg Face, 20mm ID. (note: inadvertently left out of original posting) Orthopedic hip implant component.
- Company
- Exactech, Inc.
- Recall Initiated
- June 29, 2021
- Posted
- July 22, 2021
- Recall Number
- Z-2132-2021
- Quantity
- 89,050 total
- Firm Location
- Gainesville, FL
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.
Distribution
Distribution US nationwide.
Lot / Code Info
All serial numbers. UDI-DI numbers: 138-32-XX: 10885862024732, 10885862024749, 10885862024756, 10885862024763, 10885862024770. 138-36-XX: 10885862024817, 10885862024824, 10885862024831, 10885862024848, 10885862024886, 10885862024893, 10885862024909, 10885862024916. 138-40-XX: 10885862208804, 10885862208811, 10885862208828.
Root Cause
Unknown/Undetermined by firm
Action Taken
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.