—#146870

Product

K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws

FDA product code: HXI — Passer, Wire, Orthopedic
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot 237830TE

Why it was recalled

The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA

Timeline

Recall initiated: 2016-05-20
Terminated: 2016-11-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146870. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.