—#195172

Product

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C, REF 132-22-03 b. ACUMATCH 15 DEGREE LINER 28MM SZ D, REF 13-28-04

FDA product code: MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K040613
Affected lot / code info: a. REF 132-22-03, GUIDID 10885862022882, Serial Numbers: 1191262, 1191263, 1191264, 1191265, 1191266, 1191267, 1191268, 1191269, 1191270, 1191271, 1191272, 1191273, 1264678, 1264679, 1264680, 1264681, 1264682, 1264683, 1264685, 1264686, 1264687, 1264688, 1264689, 1264690, 1264691, 1264692, 1264693, 1264694, 1264695, 1264697, 1264698, 1264699, 1264700, 1264701, 1264703, 1264704, 1632156, 1632157, 1632158, 1632159, 1632160, 1632161, 1644095, 1644096, 1644097, 1644098, 1644099, 1644100, 1644101, 1644102, 1644103, 1644104, 1644105, 1644107, 1644108, 1644109, 1644111, 1644112, 1644113, 1644114, 2668582, 2668587, 2668594, 2668606; b. REF 13-28-04, GUDID 10885862022998, Serial Numbers: 569977, 569980, 569983, 569985, 569986, 569987, 569988, 569992, 617606, 617607, 617608, 617609, 617611, 617615, 617616, 617619, 617620, 705092, 705094, 705099, 705100, 705101, 705103, 705114, 705117, 766031, 766032, 766034, 766036, 766038, 774540, 774543, 774547, 774548, 774550, 774552, 774553, 774554, 774555, 774556, 774558, 943503, 943504, 943505, 943506, 943519, 943521, 943522, 943525, 1067545, 1067546, 1067557, 1225656, 1225657, 1225658, 1225663, 1225664, 1225669, 1225679, 1225680, 1225683, 2781156, 4529972, 5247524, 5783760, 5783763, 5998768, 5998769, 5998770, 5998771, 6143949, 6143973.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

Timeline

Recall initiated: 2022-08-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195172. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.