Recall Z-1726-2022 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Exactech, Inc.
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
| 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 | 136 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
| K040613 | EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS Exactech, Inc., Jun 4, 2004 |