Agency classClass IIOur severity:High FDA (Devices)·Z-1727-2022·Announced 2022-09-21

GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

Exactech recalled 132 GXL acetabular liners (hip implant components) due to non-conforming bags that may accelerate device wear. Units were distributed worldwide to the US and 13 countries.

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 medical device recall with no reported adverse events or injuries. This involves packaging defects of an implanted orthopedic hip component that may cause accelerated wear, constituting a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Exactech, Inc. is recalling specific GXL acetabular polyethylene liners because they were packaged in non-conforming bags that may adversely impact the device and contribute to accelerated wear. The acetabular liner is a component used in hip implant surgery.

The recall affects 132 devices distributed worldwide, including throughout the United States and to 13 other countries: Argentina, Brazil, Chile, China, Colombia, Ecuador, Greece, Guatemala, India, Lebanon, Portugal, Puerto Rico, and Spain. Five different ACUMATCH product line variants are included in this recall.

If you have received or implanted one of these devices, contact your implant supplier or Exactech directly for guidance on next steps and device replacement options.

The recalled product

Product: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 b. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE J, REF 138-36-09 c. ACUMATCH LINER 15 DEG 36MM ID, SIZE H, REF 132-36-08 d.…
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic / Hip Implant
Hazard: packaging-defect
accelerated-wear
Affected units: 132

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 138-36-08
GUDID 10885862024787
Serial Numbers: 638430
638433
638451
638462
638467
b. REF 138-36-09
GUDID 10885862024794
Serial Numbers: 635279
635281
c. REF 132-36-08
GUDID 10885862023353
Serial Numbers: 630606
630607
630609
630610
630611
630612
630613

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 →

Same manufacturer · Exactech, Inc.

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