FDAMay 26, 2020device
ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
6.0x50mm poly-reduction screws were laser etched 6.0x45
What to do
FDA enforcement status: Terminated
Brands named
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Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.2026-05-22
- FDAAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.2026-05-22
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