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Recall Observatory FDA recall evidence

Device product

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

Z-2146-2023

May 18, 2023

Class II

Product summary

Firm
Aesculap Implant Systems LLC
Event
Event 92575
Status
Ongoing
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-2146-2023

Official wording

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

Code information: GUIDID: 04046963469054 Lot Number: 22002834

Distribution pattern: US Nationwide distribution in the states of DC, MO, PA, TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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