Recalls / —
—#158682
Product
Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K023186
- Affected lot / code info
- All lot numbers
Why it was recalled
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Root cause (FDA determination)
Labeling design
Action the firm took
The recalling firm issued a letter dated 9/19/2017 via email to their customers.
Recalling firm
- Firm
- Exactech, Inc.
- Address
- 2320 NW 66th Ct, Gainesville, Florida 32653-1630
Distribution
- Distribution pattern
- Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.
Timeline
- Recall initiated
- 2017-09-19
- Terminated
- 2021-06-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #158682. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.