Recall Z-0493-2020— Hager & Meisinger Gmbh

Class II · Ongoing

Class II FDA medical device recall by Hager & Meisinger Gmbh, initiated 2018-11-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:. Reason: Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging..

Recalling firm
Hager & Meisinger Gmbh
Classification
Class II
Status
Ongoing
Initiated
2018-11-07
Firm location
Dusseldorf, N/A, Germany

Product description

Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:

Reason for recall

Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.

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