CLASS II ONGOING Device recall · Reported 12 Jan 2022 · FDA Enforcement Report
Triathlon Pro Tibial Preparation Tray, Revision AC recalled
Howmedica Osteonics is recalling Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and, distributed nationwide in the US. The recall was initiated on 24 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0459-2022
- FDA event ID
- 89190
- Recalling firm
- Howmedica Osteonics, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Nov 2021
- FDA classified
- 6 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 24 Nov 2021 | Recall initiated by company | |
| 6 Jan 2022 | Classified by FDA | +43 days |
| 12 Jan 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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# 6541-9-109
Where it was distributed
US Nationwide distribution in the states of GA, MI, NC, TX.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Lots #: 0552101A596, 0552101A602 GTIN#: 07613327461503
Where was it sold?
US Nationwide distribution in the states of GA, MI, NC, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Howmedica Osteonics
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|---|---|---|---|---|---|
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | Tri Ts Baseplate Size recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | Nationwide |
| Device | CLASS II | MICS3 Angled Sagittal Saw Attachment recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | The Stryker CranialMask Tracker is a single-use device recalled | Howmedica Osteonics | Device Malfunction | Nationwide |
| Device | CLASS II | Exeter V40 Stem No recalled by Howmedica Osteonics | Howmedica Osteonics | Packaging Defects | NJ |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |