MAUDE Adverse Event Report: Waldemar Link GmbH & Co. KG Endo-Model; Centralizers, cemented

Model Number	15-2975/12
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Notified on 9/17/2026 in response to an email requesting to quarantine the product, that he opened 2 parts in a procedure on (b)(6)2026 and noticed that the parts were a different size other than the size called out on the label.There wasn't much delay in the procedure and no patient harm.The decision was made at the time to use a size 14 instead and that product was available to use and was the correct size."[customer]".
Additional Manufacturer Narrative
The production records have been inspected and reviewed.The production documents do not indicate the issue.Affected devices are being recalled under r-2026-07.

• Brand Name: Endo-Model
• Common Device Name: Centralizers, cemented
• Manufacturer (Section D): Waldemar Link GmbH & Co. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 50877889
• Report Number: 3004371426-2026-00078
• Device Sequence Number: 10690850
• Product Code: KRO
• UDI-Device Identifier: 04026575205943
• UDI-Public: 04026575205943
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-2975/12
• Device Catalogue Number: 15-2975/12
• Device Lot Number: 2627181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown