Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, p
FDA device recall Z-1379-2021 · posted 2021-04-09 · Terminated
Recall details
- Recalling firm
- Howmedica Osteonics Corp.
- Reason for recall
- The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or during impaction of the instrument in surgery.
- Action taken
- On 3/4/2021, Stryker issued an Urgent Medical Device Recall notice to customers via letter due to Stryker has initiated a voluntary, catalog number specific recall for the Specialty Triathlon TS Trial Cutting Guide, sizes 1 through 8, (Left and Right). The intent of this letter is to list hazards and harms potentially associated with the above referenced product and to list any risk mitigation factors. For questions or concerns after reviewing this letter, please contact Customer Service at (201) 831-5000.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 113 components
- Distribution
- Distribution in US to: CA,, GA, NC, NJ, NV, OK, TX, and to Canada
- Date initiated
- 2021-03-05
- Date posted
- 2021-04-09
- Date terminated
- 2024-05-10
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (K172326) | Stryker Orthopaedics | 2017-10-30 |
| TRIATHLON TRITANIUM METAL-BACKED PATELLA (K132624) | Stryker Orthopaedics | 2013-11-26 |