Recall Z-1731-2022

Reason for recall

Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.

FDA-determined cause: Process control

Action taken

The firm sent an "URGENT MEDICAL DEVICE RECALL" DEAR HEALTHCARE PROFESSIONAL COMMUNICATION on 08/11/2022 by email. The purpose of the current letter is to update surgeons regarding the implications of the packaging non-conformity on performance of the Connexion GXL and other conventional UHMWPE acetabular liners. In addition, this letter provides updates to patient management and follow-up recommendations since issuance of the July 2021 DHCP letter. In addition to providing surgeons with lists of all their affected GXL and/or conventional polyethylene patients since 2004, Exactech is providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices. The Customers were instructed to take the following actions: CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory. EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. Reach out to Customer Service at cust.svc@exac.com to request a Returned Goods (RG) Number for ALL affected product requested to be returned. WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL. If you have any questions, call (888) 912-0403.