Stryker Recalls Triathlon Modular Handle Instruments Due to Fit Issues
Stryker Howmedica Osteonics is voluntarily recalling Triathlon Modular Handle instruments because press fit specifications were not met, potentially causing disassociation.
What this means for you
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 structural defect that could lead to disassociation during surgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is voluntarily recalling the Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile. The recall involves 12,469 units distributed worldwide and across the United States. These reusable instruments are part of the Triathlon Primary total knee arthroplasty (TKA) system and the Triathlon Partial Knee Replacement (PKR) system.
The recall was initiated because analysis revealed that the press fit specifications between the dowel pin and the mating hole in the shaft were not being achieved. This defect potentially results in disassociation from the instrument. The handles are used to assist in stabilizing the Triathlon Femoral Sizer, aid in stabilization during the use and removal of the Triathlon 4:1 Cutting Block, and aid in assembly of the Anterior MIS Distal Resection Guide. In PKR surgeries, the handle is required to assemble and disassemble the Femoral Trial Drill Guide and remove the Peg Trial from the Femoral Trial.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Howmedica Osteonics for further instructions.
The recalled product
- Product
- Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S Product Usage: Is a reusable instrument that is part of the Triathlon Primary total knee arthroplasty (TKA) system as well as the Triathlon Partial Knee Replace
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Affected units
- 12,469
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. 6541-4-808 Lot Nos.: SB1K14
- SB1K14A
- SB1K14A1
- SB1K14P
- SB1K15
- SB1K15A
- SB1K15A1
- SB1K15A2
- SB1M25
- SB1M25A
- SB1M25A1
- SB1M25A2
- SB1M25A2X1
- SB1N02
- SB1N02A
- SB1N02A1
- SB1N02A2
- SB1N02A3
- SB1N02X1
- SB1T05
Distribution
Distributed nationwide across the United States.
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