FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1726-2022
- Recalling firm
- Exactech, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2022-08-11
- Posted
- not on file
- Terminated
- not on file
- 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 providing surgeons with two draft letters directed at patients who have been implanted with Exactech GXL hip devices. The Customers were instructed to take the following actions: CAREFULLY REVIEW THIS RECALL NOTIFICATION to ensure that you fully understand the issue identified, the recall strategy, and all actions required. IMMEDIATELY IDENTIFY AND QUARANTINE any of the subject devices in your inventory and/or customers inventory. EXTEND THE DESCRIPTION OF THE ISSUE AND CLINICAL IMPACT as described in the recall notification to your accounts that may have this product in their possession. COMPLETE AND RETURN the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. Reach out to Customer Service at cust.svc@exac.com to request a Returned Goods (RG) Number for ALL affected product requested to be returned. WE ARE REQUIRING 100% EFFECTIVENESS FOR THIS RECALL. If you have any questions, call (888) 912-0403.
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K040613"]
- PMA numbers
- not on file
- Product code
- MEH
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28