Recall Z-2672-2020— U&I CORP.

Name: FDA recall Z-2672-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-26

Class II · Terminated

Class II FDA medical device recall by U&I CORP., initiated 2020-05-26, terminated 2024-04-05. It names one FDA 510(k) clearance: K173524. Product: ANAX 5.5 Poly-Reduction Screw 6.0X50MM, REF: SFNA6050R, part of ANAX 5.5 SPINAL SYSTEM. Reason: 6.0x50mm poly-reduction screws were laser etched 6.0x45.

Recalling firm: U&I CORP.
Classification: Class II
Status: Terminated
Initiated: 2020-05-26
Terminated: 2024-04-05
Firm location: Uijeongbu, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K173524 — ANAX 5.5 Spinal SystemU&I Corporation·cleared 2017-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

6.0x50mm poly-reduction screws were laser etched 6.0x45

Data sourced from openFDA. This site is unofficial and independent of the FDA.