Device 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
Z-2084-2016
Product summary
- Event
- Event 74224
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182 units
- Official record key
device-enforcement:Z-2084-2016
Official wording
Reason: 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.
Code information: Lot 237830TE
Distribution pattern: Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
Derived failure modes
-
Unknown
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.