FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
- Recall number
- Z-1383-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
- Status
- Terminated
- Initiated
- 2019-09-25
- Posted
- not on file
- Terminated
- 2024-04-01
- Reason
- Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
- 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: emailorders@aesculapusa.com
- Quantity
- 7 pieces
- Distribution
- United States: TX and AK
- Lot, serial or model codes
- UDI-DI (GTIN): 04046955063277
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXK
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28