FDA recall Z-2038-2020

Product

Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

Reason for recall

The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.

Distribution

US Nationwide Distribution including in the states of Florida. No Foreign Consignees listed.

Key facts

Status

Terminated

Initiation date

2020-04-03

Report date

2020-05-27

Termination date

2020-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Laval, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2038-2020