The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1728-2022·Announced 2022-09-21

GXL Acetabular Liners Recalled Due to Non-Conforming Packaging Bags

Exactech recalls GXL acetabular hip implant liners packaged in non-conforming bags that may cause premature wear. No injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of orthopedic hip implant components with potential for accelerated wear due to packaging defect. No injuries or device failures reported, but premature implant wear constitutes a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Exactech, Inc. is recalling specific GXL acetabular liners, which are components used in hip replacement implants. These liners were distributed in non-conforming bags that do not meet product specifications.

The non-conforming packaging may adversely impact the device and contribute to accelerated wear of the acetabular liner. Accelerated wear could affect the long-term performance of the implant. No injuries or device failures have been reported.

The recall affects 11,143 devices with worldwide distribution including the United States and multiple foreign countries including Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain. Specific reference numbers and serial numbers have been identified for the affected products.

Patients with these implants should contact their surgeon or healthcare provider for guidance on their specific device. Healthcare facilities should verify their inventory against the affected serial numbers and contact Exactech for information regarding next steps.

The recalled product

Product
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE…
Manufacturer
Exactech, Inc.
Category
Medical Device — Orthopedic / Hip Implant Component
Hazard
Affected units
11,143

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a. REF 130-28-25
  • GUDID 10885862021984
  • Serial Numbers: 802593
  • 802599
  • 803717
  • 803737
  • 841318
  • 841321
  • 1572107
  • 1579369
  • 1580046
  • 1583363
  • 1613871
  • 1613872
  • 1613873
  • 1618998
  • 1638490
  • 1638492
  • 1638494
  • 1990100

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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