Recalls / —
—#185858
Product
Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer.
- FDA product code
- MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K123486, K141056
- Affected lot / code info
- Catalogue # 5536-B-400, Lot Number CTD44301
Why it was recalled
Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bottom of the internal profile of the baseplate. The taper prevents the insert from locking on the baseplate.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
On 2/11/2021, Stryker issued Urgent Medical Device Recall notices to customers via UPS 2-day air stating Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized.
Recalling firm
- Firm
- Howmedica Osteonics Corp.
- Address
- 325 Corporate Dr, Mahwah, New Jersey 07430-2006
Distribution
- Distribution pattern
- Domestic: AZ, GA, MA, MI, MN, NH, NJ, OR, PA, SC, UT, WA, WV.
Timeline
- Recall initiated
- 2021-02-10
- Terminated
- 2023-05-30
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #185858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.