Recalls / —
—#161789
Product
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.
- FDA product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K103145
- Affected lot / code info
- 906512, 906513, 906514, 906515
Why it was recalled
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
Root cause (FDA determination)
Vendor change control
Action the firm took
Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL letter dated October 16, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review inventory and quarantine affected product, which will be returned to Biomet through a sales representative. Questions or concerns can be directed to 574-371-3071
Recalling firm
- Firm
- Zimmer Biomet, Inc.
- Address
- 56 E Bell Dr, Warsaw, Indiana 46582-6989
Distribution
- Distribution pattern
- US Nationwide Distribution
Timeline
- Recall initiated
- 2017-10-11
- Terminated
- 2020-05-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #161789. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.