Z-1726-2022Class II

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER...

Name: Z-1726-2022 GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH 15 DEGREE LINER...
Creator: Exactech, Inc.
Published: 2022-08-11
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2022-08-11 / Open, Classified / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of 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... on 2022-08-11. FDA classified it as Class II and gives the reason as "Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1726-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-11
Posted: 2022-09-09
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
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Reason for recall: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Root cause tag: manufacturing process
FDA 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 [email protected]. Reach out to Customer Service at [email protected] 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 in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1726-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1725-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1726-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1727-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1728-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1729-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1730-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1731-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1732-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1733-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09
Z-1734-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-21	2022-09-09

Product code MEH

K040613Class IIExactech Acumatch a-Series and Mcs Acetabular Shells and LinersExactech, Inc. / cleared 2004-06-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)