FDA recall Z-2383-2020

Product

Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x37,5 mm Catalog Number: 18965037S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Reason for recall

Seal integrity of the blister pack may be compromised and sterility cannot be assured

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.

Key facts

Status

Terminated

Initiation date

2020-05-07

Report date

2020-06-24

Termination date

2023-09-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2383-2020