Exactech Recalls Four Novation Femoral Stems Due to Premature Packaging
Exactech is recalling four Novation femoral stems because they were packaged before the required site-change approval was granted.
What this means for you
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 source text indicates a procedural error (premature packaging) without any reported injuries, illnesses, or specific functional defects, aligning with the criteria for a moderate severity score.
Plain-English summary
Exactech, Inc. is recalling four Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stems (Catalog Number 160-00-13). These devices are intended for use in primary total hip arthroplasty. The specific units involved have serial numbers 4333544, 4333545, 4333546, and 4335281, with expiration dates of March 22, 2021, and March 23, 2021.
The recall was initiated because the devices were inadvertently sent to packaging and finished goods prior to the approval of the PMA site-change supplement. This procedural error occurred before the necessary regulatory clearance for the site change was finalized.
The four affected devices were distributed in Florida, New Jersey, New York, Ohio, Oklahoma, Rhode Island, Tennessee, Virginia, and Hawaii. Healthcare providers and facilities that have received these specific serial numbers should stop using them and contact Exactech for further instructions.
The recalled product
- Product
- Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
- Manufacturer
- Exactech, Inc.
- Affected units
- 4
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 (10)
- Product Codes: LPH
- MEH
- LWJ
- JDI
- Catalog Number 160-00-13
- Serial Numbers: 4333544
- 4333545
- 4333546
- Exp.3/22/2021 and Serial Number 4335281
- Exp. 3/23/2021.
Distribution
Part of a larger recall action
This product is one of 6 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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