TRULIANT Knee System tibial inserts recalled for packaging oxygen barrier defect
Exactech is recalling 31,201 TRULIANT Knee System tibial inserts whose packaging lacks an oxygen barrier layer. The implants were distributed worldwide.
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: FDA Class II recall for a medical device with a packaging defect that could lead to device degradation. Although no injuries or illnesses have been reported, the affected devices are knee implants that are inherently risk-of-harm products where any failure would require surgical revision.
Plain-English summary
Exactech, Inc. is recalling 31,201 TRULIANT Knee System tibial inserts in multiple configurations (CR, CR Slope+, CR Slope++, CRC, PS, and PSC) due to a packaging defect. These devices were distributed worldwide, including throughout the United States and more than 40 additional countries.
The inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer. The FDA classified this as a Class II recall.
Patients who have received these implants should consult their healthcare provider if they have concerns about this recall. Healthcare providers can identify affected devices using the detailed item numbers and serial numbers available in the official FDA recall notice.
The recalled product
- Product
- TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial…
- Manufacturer
- Exactech, Inc.
- Affected units
- 31,201
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 (20)
- a. Item Number (Device Identifier
- Serial number(s)): 02-022-47-1009 (10885862306067
- 4904358
- 4904362
- 4904363
- 4904365
- 5103012
- 5132420
- 5132432
- 5186119
- 5186125
- 5186128
- 5220427
- 5220428)
- 02-022-47-1010 (10885862306074
- 5054265
- 5054269
- 5054272
- 5058395
- 5058402
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 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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