Food, drugs, devices › Aesculap Implant Systems LLC

Device recall: AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion s

FDA enforcement event 90502 · Class II · initiated 8 Sep 2020 · status Terminated · terminated 10 Apr 2024

DeviceVoluntary: Firm initiated6 product recordsCenter Valley, PA

FDA enforcement event 90502 is a device recall by Aesculap Implant Systems LLC of Center Valley, PA, initiated 8 Sep 2020 and classified Class II, with 6 product records.

FDA defines Class II as 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. 93% of the 916 device enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 10 Apr 2024. Initiation: voluntary: firm initiated. Aesculap Implant Systems LLC has 35 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Aesculap Implant Systems LLC, Center Valley, PA.

Reason for recall

"Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion."

Distribution

"United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-1443-2022	AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, product code SW112T. Used in spinal fusion surgery.	24	Class II	Terminated	27 Jul 2022
Z-1444-2022	AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.	24	Class II	Terminated	27 Jul 2022
Z-1445-2022	AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, product code SW114T. Used in spinal fusion surgery.	24	Class II	Terminated	27 Jul 2022
Z-1446-2022	AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T. Used in spinal fusion surgery.	23	Class II	Terminated	27 Jul 2022
Z-1447-2022	AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE 33-42MM, product code SW116T. Used in spinal fusion surgery.	20	Class II	Terminated	27 Jul 2022
Z-1448-2022	AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE 42-58MM, product code SW117T. Used in spinal fusion surgery.	27	Class II	Terminated	27 Jul 2022

Context

93%of 2020 device events are Class II916 events that year

6product records in this eventfirm median: 1

35events on this register for the firm

Other enforcement events for 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

All 35 events for Aesculap Implant Systems LLC

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is 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.

Where was the product distributed?

FDA's distribution pattern field reads: "United States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC, NV, OH, PA, SC, TX & WY."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Apr 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.