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

Class II FDA enforcement event 90493. Recall start date: 1 Apr 2020. Status in the FDA record: Completed.

Reason for recall, in the words of FDA

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

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Aesculap Implant Systems LLC started this device recall on 1 Apr 2020. The firm address in the FDA record is in Center Valley, PA. FDA put the recall in Class II. FDA event 90493 has 2 product records. The first FDA enforcement report date is 10 Aug 2022. The record gives the status Completed.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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,…

Recalling firm

Aesculap Implant Systems LLC, Center Valley, PA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 90493: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1481-2022	PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8360-10	3392	Class II	Completed	10 Aug 2022
Z-1482-2022	PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10	399	Class II	Completed	10 Aug 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 35

Other events of the firm

Other FDA enforcement events of Aesculap Implant Systems LLC
Initiated	Product (first record)	Type	Class	Records
20 Jul 2023	For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R	Device	Class II	1
18 May 2023	Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, non-sterile, reusable Article Number: MD610	Device	Class II	1
21 Mar 2023	Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagulation device for cutting/coagulation/ablati	Device	Class II	1
23 Feb 2023	Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cervical Retractor (CCR) Basket Full System - L	Device	Class II	1
15 Jul 2022	Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the l	Device	Class II	1
14 Jul 2022	Aeos Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010	Device	Class II	1
25 Oct 2021	MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441	Device	Class II	1
30 Jun 2021	RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.	Device	Class II	2
16 Apr 2021	PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU	Device	Class II	2
19 Mar 2021	Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471	Device	Class II	8

Aesculap Implant Systems LLC: all 35 events

Official channels

FDA enforcement report Z-1481-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 90493. https://recallregister.com/fda/ii/90493/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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,…
What quantity of product is in FDA event 90493?: The event has 2 product records. The first record gives this quantity: 3392
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.