Exactech Recalls Truliant Tibial Trial Handles Due to Pin Disassociation Risk
Exactech is recalling 68 Truliant Tibial Trial Handles because the pin may disassociate from the main body. The devices were distributed to 11 states.
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 is classified as FDA Class II, and the hazard involves a structural defect in a surgically invasive instrument where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Exactech, Inc. is recalling 68 units of the Truliant Tibial Trial Handle. These reusable surgical instruments are intended to assist surgeons in the implantation of Truliant Knee system components during total knee replacement procedures.
The recall was initiated because the pin on the handle may disassociate from the main body. This defect could potentially compromise the instrument's function during surgery.
The affected devices, identified by Catalog Number 02-029-29-1000 and Lot Number 83843-001, were distributed to the states of Arizona, California, Colorado, Florida, Illinois, Ohio, Oklahoma, Nevada, New York, South Carolina, and Tennessee. Healthcare facilities and users should stop using these specific handles and contact Exactech for further instructions.
The recalled product
- Product
- Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to a conventional technique for total knee replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.t…
- Manufacturer
- Exactech, Inc.
- Affected units
- 68
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 (2)
- Catalog Number 02-029-29-1000
- Lot Number 83843-001.
Distribution
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