Integra LifeSciences Corp.: Medical Device Recall in 2016 - (Recall #: Z-2084-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 20, 2016

Date Posted: July 6, 2016

Recall Number: Z-2084-2016

Event ID: 74224

Reason for Recall:

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.

Status: Terminated

Product Quantity: 182 units

Code Information:

Lot 237830TE

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated