Recall Z-1045-2023— MEDLINE INDUSTRIES, LP - Northfield

Name: FDA recall Z-1045-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-22

Class II · Ongoing

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2022-12-22. It names one FDA 510(k) clearance: K181280. Product: MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008. Reason: The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque..

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Classification: Class II
Status: Ongoing
Initiated: 2022-12-22
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K181280 — Patello-Femoral Wave (Kahuna) Arthroplasty SystemArthrosurface, Inc.·cleared 2018-06-14

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

MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008

Reason for recall

The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.

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