TunneLoc Tibial Fixation Device Product Usage: To recall
TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament…
Why was TunneLoc Tibial Fixation Device Product Usage: To recalled?
Gamma sterilization validation testing indicates the sterilization dose for the product may not be adequate.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
906512, 906513, 906514, 906515
- Product
- TunneLoc Tibial Fixation Device Product Usage: To provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 14,461
- Distribution
- US Nationwide Distribution
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)