Exactech Recalls Eight Hip Implant Stems Lacking Coating
Exactech is recalling eight Novation Element femoral hip implant stems that did not receive the specified Hydroxyapatite coating.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where the specified coating was not applied, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling eight Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems. These devices are intended for press-fit fixation.
The recall was initiated because the eight affected pieces did not receive the specified Hydroxyapatite (HA) coating. The products were distributed in the United States to the states of Arizona, Colorado, Florida, and Maryland.
The affected units are identified by Catalog Number 164-13-09 and Serial Numbers 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822. Healthcare providers and patients should contact Exactech, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
- 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 (8)
- Catalog Number 164-13-09 Serial Numbers: 4076815
- 4076816
- 4076817
- 4076818
- 4076819
- 4076820
- 4076821
- and 4076822.
Distribution
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