Aesculap Implant Systems LLC: PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

Is my product affected?

PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10

• UPC 04046955083381

Check against the official notice below — it lists the full affected range.

What happened

Aesculap Implant Systems LLC is recalling 399 PRESTIGE RETRACTION GRASPER devices (Product Code 8361-10) distributed nationwide across all U.S. states, Washington DC, and Puerto Rico. The devices may become separated at the weld connecting the handle to the shaft. The affected lots are M45171, M46651, M47463, M48124, and M49436, which can be identified using the UDI-DI number 04046955083381.

The recall record does not specify a remedy or instructions for what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Endoscopic graspers may become separated at the weld from handle to the shaft of the device.

Details from the source

Reason for recall: Endoscopic graspers may become separated at the weld from handle to the shaft of the device. Distribution: United States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Washington DC and Puerto Rico. Quantity: 399 Lot/code info: UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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