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Terminated

ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM

FDA Recall Z-2672-2020 · Posted None

Recalling FirmU&I CORP.
Recall StatusTerminated
Product CodeNKB
Date Initiated2020-05-26
Date Terminated2024-04-05
Product Quantity6

Reason for Recall

6.0x50mm poly-reduction screws were laser etched 6.0x45

Firm 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.

Root Cause

Process control

Distribution Pattern

U.S.: AZ

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K173524ANAX 5.5™ Spinal SystemU&I Corporation · 2017-12-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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