Recall archive / FDA device enforcement
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER 22MM SZ C,... — FDA record Z-1726-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
- Classification
- Class II
- Recalling firm
- Exactech, Inc.
- Quantity
- 136 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1726-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Sep 21, 2022
- Recall initiation date
- Aug 11, 2022
- Center classification date
- Sep 9, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.