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 arthroplasty (TKA). Catalog#
Check against the official notice below — it lists the full affected range.
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays distributed nationwide in Georgia, Michigan, North Carolina, and Texas. The trays may contain an incorrect instrument—the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the correct Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y). Seven units were affected, identified by lot numbers 0552101A596 and 0552101A602.
If the incorrect instrument is used during surgery, it could cause delays or result in unintended bone preparation. The recall source does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation
Reason for recall: Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation Distribution: US Nationwide distribution in the states of GA, MI, NC, TX. Quantity: 7 units Lot/code info: Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.