Smith & Nephew, Inc.: Medical Device Recall in 2017 - (Recall #: Z-0097-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

Product Classification:

Class II

Date Initiated: October 24, 2017

Date Posted: November 22, 2017

Recall Number: Z-0097-2018

Event ID: 78390

Reason for Recall:

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

Status: Ongoing

Product Quantity: 17 units

Code Information:

Lot number 16LM07111

Distribution Pattern:

US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

Voluntary or Mandated:

Voluntary: Firm initiated