—#154857

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.

FDA product code: MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K091549
Affected lot / code info: Lot Number 786351

Why it was recalled

Manufactured with the incorrect anchor outer body

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

Firm: ConMed Corporation
Address: 525 French Rd, Utica, New York 13502-5945

Distribution

Distribution pattern: CA, IN, KS, MD, NY, OH, PA, TN, TX & WI

Timeline

Recall initiated: 2017-04-17
Terminated: 2021-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154857. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.