Z-2123-2021Class II

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers...

Name: Z-2123-2021 Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers...
Creator: Exactech, Inc.
Published: 2021-06-29
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2021-06-29 / Open, Classified

FDA source

Exactech, Inc. began a recall of Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation... on 2021-06-29. FDA classified it as Class II and gives the reason as "Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2123-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-06-29
Posted: 2021-07-22
Recalling firm: Exactech, Inc.
Product: Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm; Novation GXL Liner, Lipped, 40mm. Orthopedic hip implant component.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
FDA root cause: Unknown/Undetermined by firm
Action: The firm issued "URGENT MEDICAL DEVICE CORRECTION" letters dated 6/28/2021 via email on 6/29/2021 that were addressed to the attention of Exactech Agents, Representatives, and Distributors in possession of affected products.
Quantity in commerce: 89,050 total
Distribution: Distribution US nationwide.
Product codes and lots: All serial numbers. UDI-DI numbers: 10885862207043, 10885862207050, 10885862207067, 10885862303349, 10885862303462, 10885862303363

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2123-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2112-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2113-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2114-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2115-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2116-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2117-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2118-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2119-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2120-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2121-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2122-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2123-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2124-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2125-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2126-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2127-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2128-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2129-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2130-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2131-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2132-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22
Z-2133-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-28	2021-07-22

Product code LPH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)