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Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA… recallZ-2146-2023 · Aesculap Implant Systems LLC · initiated May 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Incorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610.

FDA root cause category: Labeling Change Control

What the company is doing

Aesculap Inc, a B. Braun company issued Urgent Medical Device Recall Notification Letter dated 5/18/23. Letter states reason for recall, health risk and action to take: Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and all concerned persons are informed about this voluntary product recall. 2. Determine your current inventory of the affected product within your facility. (See for instructions in identifying impacted devices.) 3. Cease use and quarantine product subject to recall. 4. Utilizing the attached "Product Recall Acknowledgement Form", record the total number of individual impacted pieces. If you have no inventory remaining, please enter zero (0) on the form. 5. Return the completed "Product Recall Acknowledgement Form" to Aesculap, Inc. Product Quality Excellence department by emailing the form to PA OualityAssurance.BBMUS [email protected] or faxing the form to (610) 849-1197 within two weeks of receipt, even if the total inventory in your possession is zero (0). 6. Once Aesculap, Inc. receives your acknowledgement form, a customer support representative will contact you with instructions on how to return any impacted pieces in your possession. Complete the acknowledgment form. Included with letter Instructions for Identifying Affected MD610 etched as MD611.

Recall details

Recall number
Z-2146-2023
Status
Open, Classified
Initiated by the company
May 18, 2023
Posted by the FDA
Jul 14, 2023
Recalling firm
Aesculap Implant Systems LLC
Quantity
7 units
Product code
HXK
Distribution
US Nationwide distribution in the states of DC, MO, PA, TX.

Product description

Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610

Code information (models, lots, serial numbers)

GUIDID: 04046963469054 Lot Number: 22002834

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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