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).
What this means for you
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, osteonec
- Manufacturer
- Exactech, Inc.
- Hazard
- 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
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.
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