Z-1383-2022Class II

AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to...

Name: Z-1383-2022 AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to...
Creator: Aesculap Implant Systems LLC
Published: 2019-09-25
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2019-09-25 / Terminated / root cause: labeling and UDI

FDA source

Aesculap Implant Systems LLC began a recall of AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle on 2019-09-25. FDA classified it as Class II and gives the reason as "Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1383-2022
Classification: Class II
Status: Terminated
Initiated: 2019-09-25
Posted: 2022-07-13
Terminated: 2024-04-01
Recalling firm: Aesculap Inc
Product: AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Product code: HXK Holder, Needle; Orthopedic
Reason for recall: Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Field Action Notification letter was issued September 25, 2019 via letter sent USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or via email at: [email protected]
Quantity in commerce: 7 pieces
Distribution: United States: TX and AK
Product codes and lots: UDI-DI (GTIN): 04046955063277

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1383-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1383-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-20	2022-07-13

Product code HXK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)