PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Summary
The FDA issued a Class II for PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH by Aesculap Implant Systems LLC. Reason: Endoscopic graspers may become separated at the weld from handle to the shaft of the device..
Details
Source
Device Recall
External ID
Z-1482-2022
Action Date
2022-08-10
Status
Completed
Category
device
Product Description
PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Lot/Code Info: UDI-DI: 04046955083381, lots M45171; M46651; M47463; M48124; M49436.
Quantity Affected: 399
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2020-04-01
Company
Center Valley, PA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 97 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aesculap Implant Systems LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aesculap Implant Systems LLC have FDA actions?
Aesculap Implant Systems LLC has 34 FDA actions in our database, including 33 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1482-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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