Z-2945-2018 Class II Terminated
FDA device recall Z-2945-2018 was initiated by Ceterix Orthopedics, Inc. on May 16, 2018 and is designated Class II. Reason for recall: Possible nonconforming blades may result in a higher than specified cut force required to cut the suture. The recall status is terminated (terminated August 24, 2020). Affected quantity: 96 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- May 16, 2018
- Termination Date
- August 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 96 units
Product Description
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Reason for Recall
Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.
Distribution Pattern
United States distribution.
Code Information
Lot#M180018