FDA recall Z-1727-2022

Exactech, Inc. · Class II · device

Product

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d. ACUMATCH LINER 15 DEG 36MM ID, SIZE J, REF 132-36-09 e. ACUMATCH LINER 15 DEG 36MM ID, SIZE K, REF 132-36-10

Reason for recall

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

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2022-08-11
Report date: 2022-09-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1727-2022