Z-0253-2018 Class II Terminated
FDA device recall Z-0253-2018 was initiated by ConMed Corporation on April 17, 2017 and is designated Class II. Reason for recall: Manufactured with the incorrect anchor outer body The recall status is terminated (terminated August 31, 2021). Affected quantity: 56 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 20, 2017
- Initiation Date
- April 17, 2017
- Termination Date
- August 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 56 units
Product Description
Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
Reason for Recall
Manufactured with the incorrect anchor outer body
Distribution Pattern
CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
Code Information
Lot Number 786351