FDA recall Z-0563-2020

Product

ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

Reason for recall

The firm discovered a lack of adequate documentation confirming sterility on certain products.

Distribution

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

Key facts

Status

Terminated

Initiation date

2016-11-08

Report date

2019-12-04

Termination date

2020-11-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0563-2020