Zimmer Biomet Recalls TunneLoc Tibial Fixation Devices Due to Sterilization Concerns
Zimmer Biomet is recalling TunneLoc Tibial Fixation Devices because testing suggests the sterilization dose may be inadequate. The devices are distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential failure in sterilization validation for a medical device, which poses a risk of infection or harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling the TunneLoc Tibial Fixation Device, which is included in ACL kits. 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 affected kits, identified by part numbers 906532, 906533, 906534, and 906535, are distributed non-sterile across the United States.
The recall was initiated because gamma sterilization validation testing indicates that the sterilization dose for the product may not be adequate. This potential deficiency raises concerns regarding the sterility of the devices.
Healthcare providers and facilities that have received these kits should stop using the affected products and contact Zimmer Biomet for further instructions. Consumers are not directly affected as these are professional medical devices.
The recalled product
- Product
- TunneLoc Tibial Fixation Device (Within an ACL Kit) 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.
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 (5)
- The kits that include the TunneLoc products
- ACL in a box
- PNs 906532
- 906533
- 906534
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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