FDA Medical Device Recalls (openFDA)
U&I CORP.: ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
- Recall number
- Z-2672-2020
- Recalling firm
- U&I CORP.
- Product
- ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM
- Status
- Terminated
- Initiated
- 2020-05-26
- Posted
- not on file
- Terminated
- 2024-04-05
- Reason
- 6.0x50mm poly-reduction screws were laser etched 6.0x45
- Root cause
- Process control
- Action
- On 05/26/20, a Request to Return Products Which Have Laser Marking Issue notice was sent to the firm customer. The customer was first asked to distinguish and isolate affected product and then to return affected product. This customer/distributor sent Notification for Sales Suspension and Product Recall notices to their customers. Customers were asked to return affected product and to fill out and return the Notification for Sales Suspension and Product Recall notices to acknowledge receipt.
- Quantity
- 6
- Distribution
- U.S.: AZ
- Lot, serial or model codes
- Lot #: 19C12063
- 510(k) numbers
- ["K173524"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3003200961
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28