U&I CORP. recalls ANAX 5.5 Poly-Reduction Screws with laser etching error that may cause improper fit. Affected units include Lot #19C12063.
6.0x50mm poly-reduction screws were laser etched 6.0x45
U&I CORP. is recalling ANAX 5.5 Poly-Reduction Screws that were laser etched incorrectly as 6.0x45 instead of 6.0x50mm. This could lead to improper spinal surgery fittings if used without correction.
The screws were laser etched incorrectly as 6.0x45mm instead of 6.0x50mm. This mismatch could cause improper spinal hardware fitting during surgery, potentially leading to complications.
Surgical patients and medical professionals using the ANAX 5.5 Spinal System with the affected screws. Those who have the Lot #19C12063 screws are most at risk.
Check for the ANAX 5.5 Poly-Reduction Screw 6.0X50MM with reference number SFNA6050R. Affected units have Lot #19C12063.
Look for the lot number 19C12063 on the screw packaging or label.
The screws were laser etched as 6.0x45mm instead of the correct 6.0x50mm size.
Check for the lot number 19C12063 on the ANAX 5.5 Poly-Reduction Screw 6.0X50MM with reference number SFNA6050R.
The recall does not specify a stop-use action; check the lot number to confirm if affected.
We’ve drafted a message you can send U&I CORP. to request your refund or repair — edit it as you like.
Subject: Recall Z-2672-2020 — U&I CORP. U&I CORP. Hello, I own a U&I CORP. that is covered by recall Z-2672-2020 from U&I CORP.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.