Aesculap Implant Systems LLC: PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

Is my product affected?

PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10

• UPC 04046955083374

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

What happened

Aesculap Implant Systems LLC is recalling 3,392 PRESTIGE ATRAUMATIC GRASPER devices (5mm diameter, 36cm length, Product Code 8360-10) distributed nationwide across all U.S. states, Washington DC, and Puerto Rico. The endoscopic graspers may separate at the weld connecting the handle to the shaft, creating a safety hazard during use.

The affected devices are identified by UDI-DI number 04046955083374 and include 22 specific lot numbers ranging from M45041 through M55796. The source document does not specify a remedy for affected consumers.

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: 3392 Lot/code info: UDI-DI: 04046955083374, lots M45041; M45399; M45711; M46069; M46350; M47462; M47893; M48115; M48279; M48346; M48467; M48596; M48753; M48848; M48907; M49375; M49435; M49632; M49683; M49711; M49867; M55796.

Source

Official record: FDA (Device enforcement) ↗

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

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