FDA recall Z-0200-2019

Product

Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.

Reason for recall

One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.

Distribution

US Distribution to the states of: KS and TN.

Key facts

Status

Terminated

Initiation date

2018-09-18

Report date

2018-10-31

Termination date

2019-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0200-2019