Agency classClass IIOur severity:Low FDA (Devices)·Z-2127-2016·Announced 2016-07-13

Exactech Recalls Hip Replacement Stems Due to Incorrect GTIN Labeling

Exactech is recalling 8 units of Novation Press-Fit Splined Femoral Stems because they are labeled with an incorrect Global Trade Item Number (GTIN).

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 documentation and labeling issue (incorrect GTIN) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Exactech, Inc. is recalling 8 units of Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. The recall was initiated because the devices are labeled with an incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another product.

The affected devices are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement. The specific units involved have Catalog # 160-33-17 and Serial #s 4192419, 4192420, 4223628, 4223629, 4223630, 4223631, 4223632, and 4223633. The expiration dates for these units are 11/28/2020 and 01/02/2021.

The devices were distributed nationwide to Oklahoma, Maine, New York, and Hawaii. Healthcare providers and patients should contact Exactech, Inc. for further information regarding this recall.

The recalled product

Product: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis…
Manufacturer: Exactech, Inc.
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
Affected units: 8

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 (11)

Catalog #: 160-33-17
Serial#: 4192419
4192420
Exp Date: 11/28/2020. Catalog #: 160-33-17
Serial#: 4223628
4223629
4223630
4223631
4223632
4223633
Exp Date: 01/02/2021.

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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