Exactech Recalls Logic Fit Tibial Tamp Heads for Labeling Clarification
Exactech, Inc. is recalling 573 Logic Fit Tibial Tamp Heads to update surgical labeling. The update clarifies proper removal techniques to prevent instrument breakage.
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 2/5 (Moderate).
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: This is an FDA Class II recall involving a labeling update to clarify surgical technique and prevent instrument breakage, which aligns with the rubric for moderate severity issues involving minor labeling errors or precautionary measures.
Plain-English summary
Exactech, Inc. is recalling 573 units of the Logic Fit Tibial Tamp Head. The recall is initiated to update the surgical technique labeling to clarify the proper technique and instrumentation required to remove the tamp assembly from the bone.
The specific hazard identified is the potential for instrument breakage if the tamp handle or guide is misused by impacting in a retrograde manner. The updated labeling includes a caution statement regarding this risk.
The affected units are distributed across numerous U.S. states, including Alabama, Arizona, California, and others, as well as in Puerto Rico and several international locations including Australia, France, Germany, and the United Kingdom. Specific lot numbers and catalog numbers are listed in the agency's recall record. Healthcare providers should review the updated labeling and ensure proper surgical technique is followed to avoid instrument damage.
The recalled product
- Product
- Logic Fit Tibial Tamp Head
- Manufacturer
- Exactech, Inc.
- Affected units
- 573
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 (19)
- Catalog #: 213-75-01 Lot #'s: 37166-002
- 44944-004
- 44944-005
- 44944-006
- 48073-010
- 48073-011
- 48073-012
- 49036-017
- 51180-004
- 51180-005
- 51180-006
- 51180-008
- 51754-031
- 51754-032
- 51754-033
- 51754-034
- 59743-001
- 61872-001
- and 61872-002.
Distribution
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