Recall Z-1734-2022 · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Exactech, Inc.

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 0 DEGREE LINER 28MM 46MM, REF 130-28-05; b. ACUMATCH 0 DEGREE LINER 28MM 48MM, REF 130-28-06; c. ACUMATCH 0 DEGREE LINER 28MM 50/52MM, REF 130-28-07; d. ACUMATCH 0 DEGREE LINER 28MM 54/56MM, REF 130-28-08; e. ACUMATCH 0 DEGREE LINER 28MM 58/64MM, REF 130-28-09; f. ACUMATCH 15 DEGREE LINER 22MM SZ D,

Date	Aug 11, 2022
Status	Open, Classified
Reason	Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Root cause	Process control
Action	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 providi
Quantity	7946 devices
Distribution	Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
FDA record	Open on fda.gov

510(k) clearances named in this recall

K993082

EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT
Exactech, Inc., Nov 19, 1999