Recall Z-0253-2018
ConMed Corporation · initiated April 17, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Number 786351
Reason for recall
Manufactured with the incorrect anchor outer body
FDA-determined cause: Mixed-up of materials/components
Action taken
On April 17, 2017 CONMED distributed Urgent Device Recall notices and business reply forms to customers via USPS First Class. Customers are instructed to stop use of the devices immediately and to review inventory for any of the affected product. CONMED requests that customers contact all departments within their facilities and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive the notice and respond immediately. Customers who have received affected product are expected to complete the Business Reply Form and return it with unused devices. Customers who do not have any affected devices to return are still advised to complete and return the Business Reply Form via email to: largpop@conmed.com. Customers with questions can contact the Field Action Support Team at 1-800-237-0169.
Details
- Recall number
- Z-0253-2018
- Initiated
- April 17, 2017
- Terminated
- August 31, 2021
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 56 units
- Distribution
- CA, IN, KS, MD, NY, OH, PA, TN, TX & WI
- Recalling firm
- ConMed Corporation, Utica, NY