Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - 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-2379-2020
Product Description
Stryker Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - 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
- US 3; OUS 13
- 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 Locking Screw, Partially Threaded T2 Tibia ¿5x55 mm Catalog Number: 18915055S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.. Recalled by Stryker GmbH. Units affected: US 3; OUS 13.
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-2379-2020.
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