PlainRecalls
FDA Devices Moderate Class II Terminated

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.

Reported: June 24, 2020 Initiated: May 7, 2020 #Z-2374-2020

Product Description

Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - 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

Details

Recalling Firm
Stryker GmbH
Units Affected
26 OUS
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.
Location
Selzach

Frequently Asked Questions

What product was recalled?
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.. Recalled by Stryker GmbH. Units affected: 26 OUS.
Why was this product recalled?
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Which agency issued this recall?
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2374-2020.