Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns
Zimmer Biomet is recalling 14,461 TunneLoc Tibial Fixation Devices because gamma sterilization testing suggests the sterilization dose may be inadequate.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential contamination or sterilization failures in medical devices.
Plain-English summary
Zimmer Biomet, Inc. is recalling 14,461 units of the TunneLoc Tibial Fixation Device. These devices are used to provide fixation of soft tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction. The recall was initiated because gamma sterilization validation testing indicates that the sterilization dose for the product may not be adequate.
The affected devices were distributed nationwide in the United States. The specific product codes involved in this recall are 906512, 906513, 906514, and 906515.
Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions on the recall process.
The recalled product
- 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.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 14,461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 906512
- 906513
- 906514
- 906515
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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