Data Foundry

Medical device recalls 2021

Exactech Connexion GXL acetabular polyethylene liners used in the… — Class II medical device recall Z-2122-2021

Ongoing recall by Exactech, Inc., reported 2021-07-28, distributed nationwide. Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain i

Recall numberZ-2122-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmExactech, Inc., Gainesville, FL, United States
Recall initiated2021-06-29
Classified2021-07-22
Reported by FDA2021-07-28
DistributedNationwide (US)
Quantity89,050 total
UPC / GTIN / UDI-DI10885862023384, 10885862023391, 10885862023407, 10885862023414, 10885862023421, 10885862023438, 10885862023445, 10885862303332, 10885862303455, 10885862303462, 10885862303479
Serial numbers10885862023384, 10885862023391, 10885862023407, 10885862023414, 10885862023421, 10885862023438, 10885862023445, 10885862303332, 10885862303455, 10885862303462, 10885862303479
Model numbers132-36-XX

Product

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-36-XX, Acumatch GXL 15 Degree Liner, 36mm, and Novation GXL Liner, Lipped Ant, 36mm; and Novation GXL Liner, Lipped, 36mm. Orthopedic hip implant component.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2122-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.