Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1031-2017·Announced 2017-01-25

Exactech Recalls Polyethylene Acetabular Liners Due to Incorrect GTIN Labels

Exactech, Inc. is recalling 12 polyethylene acetabular liners because they were labeled with incorrect Global Trade Item Numbers (GTINs).

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to incorrect labeling (GTIN) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Exactech, Inc. is recalling 12 units of the AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J. The recall was initiated because the devices were labeled with incorrect Global Trade Item Numbers (GTINs). The GTINs on the labels incorrectly identify the devices as a different product.

The affected devices are identified by Serial Numbers 4507932 through 4507943, Catalog Number 138-36-29, and UDI 10885862024831. These devices were distributed to facilities in Arizona, California, Colorado, Florida, Illinois, Kansas, Maryland, New Jersey, New York, Ohio, Oklahoma, Tennessee, and Virginia, as well as in Germany, Italy, Japan, Spain, and Switzerland.

The FDA has classified this recall as Class II. No specific instructions for consumers are provided in the source text, but the recall is limited to the specific serial numbers listed above.

The recalled product

Product: AcuMatch A-Series Connexion GXL Enhanced Polyethylene Acetabular Liner, 15, +5 mm Lateralized, 36 mm I.D., Size J.
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 12

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 (3)

Serial No. 4507932-4507943
Catalog No. 138-36-29
UDI: 10885862024831

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Exactech, Inc.

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