Recall Z-1730-2022 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Exactech, Inc.
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45
| 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 | 2319 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
| K071676 | EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS Exactech, Inc., Jul 19, 2007 |