Surgical Instrument Tray Recalled for Incorrect Keel Punch Component
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard involves incorrect surgical instruments that could delay surgery or cause unintended bone preparation, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Triathlon Pro Tibial Preparation Tray is a medical device designed to organize and transport reusable surgical instruments used during total knee arthroplasty (knee replacement) procedures. The device is manufactured by Howmedica Osteonics Corp.
Affected trays may have been incorrectly kitted with the Triathlon Cemented #1-3 Keel Punch (Part Number 6541-2-013) instead of the correct Triathlon Pro #0-3 Cemented Keel Punch (Part Number 6541-2-013Y). If the wrong instrument is used during surgery, it could result in surgical delays or unintended bone preparation.
The recall involves 7 units with lot numbers 0552101A596 and 0552101A602. These trays have been distributed nationwide in Georgia, Michigan, North Carolina, and Texas.
Healthcare facilities and surgical centers that received these trays should verify the instrument part numbers before use. Contact Howmedica Osteonics Corp. if you have questions about affected units.
The recalled product
- Product
- Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usable instruments required for implanting the Triathlon Globalization Implant System for individual patients receiving primary total knee…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 7
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)
- Lots #: 0552101A596
- 0552101A602 GTIN#: 07613327461503
Distribution
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