Stryker Recalls Triathlon MIS Modular Distal Capture Instruments
Stryker is recalling specific lots of Triathlon MIS Modular Distal Capture instruments because they may disassociate during use.
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 with a functional defect (disassociation) that poses a risk of harm during surgery, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling various lots of the Triathlon MIS Modular Distal Capture instruments. The product is a surgical instrument used for knee prosthesis implantation, specifically for the distal femoral resection in a Triathlon primary MIS TKA.
The recall was initiated because complaints were received indicating that specific lots of this product may disassociate during use. The affected units were distributed nationwide, including in Arizona, Delaware, Idaho, Illinois, Kansas, Louisiana, Michigan, New Hampshire, New Mexico, New Jersey, New York, Ohio, Pennsylvania, Texas, Virginia, Vermont, Washington, and Wisconsin.
Healthcare providers and patients should stop using the affected lots immediately. Stryker is the recalling firm responsible for managing the recall of these 3,444 units.
The recalled product
- Product
- Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 3,444
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)
- Catalog No: 6541-5-723 Lot Nos.: AF1C00
- AF1C00A
- AF1C00S1
- AF1C11
- AF1C11A
- AF1C11AR
- AF1C11AR1
- AF1C11J
- AF1C11JR
- AF1C11M
- AF1C11MT
- AF1C11X1
- AF1C12
- AF1C12R
- AF1E01
- AF1E01D
- AF1E01D1
- AF1E01D1R
- AF1E01M
- AF1E01MR
Distribution
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