Agency classClass IIOur severity:Low FDA (Devices)·Z-2128-2016·Announced 2016-07-13

Exactech Recalls Novation Hip Stems Due to Incorrect GTIN Labeling

Exactech is recalling 14 Novation femoral stems because they were labeled with an incorrect Global Trade Item Number (GTIN). The error identifies the devices as a different product.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a labeling error (incorrect GTIN) which is a documentation issue. The rubric classifies documentation issues and packaging-only problems as Low severity (Score 1).

Plain-English summary

Exactech, Inc. is recalling 14 units of Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. These medical devices are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to conditions such as osteoarthritis, rheumatoid arthritis, and osteonecrosis.

The recall was initiated because the devices were labeled with an incorrect Global Trade Item Number (GTIN). The GTIN on the label incorrectly identifies the devices as another product. The affected units are distributed nationwide to Oklahoma, Maine, New York, and Hawaii.

The recall involves specific catalog and serial numbers with expiration dates in 2021. Consumers and healthcare providers should verify the GTIN on the device labels against the recall notice to determine if their inventory is affected. If the devices match the recalled serial numbers, they should be removed from use and returned to the manufacturer or distributor.

The recalled product

Product: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 18. Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis…
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
Affected units: 14

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 (17)

Catalog #: 160-33-18
Serial#: 4300062
4300063
Exp Date: 02/27/2021. Catalog #: 160-33-18
Serial#:4325742
4325743
4325744
4325745
4325746
4325747
4325748
4325749
4325750
4325751
4325752
4325753
Exp Date: 03/17/2021.

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Exactech, Inc.

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Same hazard · mis labeling