Aesculap Implant Systems LLC

Complete recall history across all FDA and CPSC categories — 61 total recalls

Aesculap Implant Systems LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (61)

FDA medical device enforcement actions by Aesculap Implant Systems LLC. Showing most recent 50.

Date Product Reason Class
Jul 20, 2023 For intraventricular indications mainly used for operations within the brain ... Trocar manufactured with the shaft too long and does not meet manufacturing s... Class II
May 18, 2023 Aesculap Surgical Needle, straight, 3 1/2", (90 mm), 13GA, width: 2,400 mm, n... Incorrect product code marked on the product, etched with product code MD611,... Class II
Mar 21, 2023 Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... Potential for the spring to become loose and fall out of the device, if the s... Class II
Feb 23, 2023 Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and ME764 Casper Cer... Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct... Class II
Jul 15, 2022 Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmenta... Potential for the incorrect screw to be included in the package. Class II
Jul 14, 2022 Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Artic... Application error problems: Rebalance scope message: 1.Rebalancing process 2.... Class II
Oct 25, 2021 MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium I... Set screwdriver fails during surgery by deforming at the tip during engagemen... Class II
Jun 30, 2021 LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery. Customized coronal rod benders may deform the implant when used with the spin... Class II
Jun 30, 2021 RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery. Customized coronal rod benders may deform the implant when used with the spin... Class II
Apr 16, 2021 PAS-PORT PROXIMAL ANASTOMOSIS DEVICE US Catalog Number: FG-000001-13 Malfuncton-Implant did not deploy successfully may necessitate the need for ... Class II
Apr 16, 2021 PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU Malfuncton-Implant did not deploy successfully may necessitate the need for ... Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL482... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL488... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System Tray Sysem knee implant devices as follows: Tray Number/... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL476... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NO180... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL494... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NO156... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Mar 19, 2021 Univation X System knee implant devices as follows: Catalog/Product: NL470... Malfunction- loosening of the implant resulting in a potential revision surgery Class II
Feb 19, 2021 Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Micro... Malfunction of the robotic arm preventing further movement of the robotic arm... Class II
Nov 18, 2020 ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Fracture or breakage of the spinal fixation arm at the downtube instrument if... Class II
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, ... Insufficient clamping force of the cross connectors in the spinal surgical sy... Class II
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, p... Insufficient clamping force of the cross connectors in the spinal surgical sy... Class II
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical sy... Class II
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical sy... Class II
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical sy... Class II
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, ... Insufficient clamping force of the cross connectors in the spinal surgical sy... Class II
Jul 13, 2020 ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Fracture or breakage of the spinal fixation arm at the downtube instrument if... Class II
Apr 1, 2020 PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENG... Endoscopic graspers may become separated at the weld from handle to the shaft... Class II
Apr 1, 2020 PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LEN... Endoscopic graspers may become separated at the weld from handle to the shaft... Class II
Jan 21, 2020 COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes,... Low Density Polyethylene (LDPE) particles may be present on the surface of th... Class II
Jan 21, 2020 AS COLUMBUS CR/PS TIB.PLAT.CEMENTED,Knee implant components, various sizes, ... Low Density Polyethylene (LDPE) particles may be present on the surface of th... Class II
Jan 21, 2020 COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, m... Low Density Polyethylene (LDPE) particles may be present on the surface of th... Class II
Jan 21, 2020 COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, m... Low Density Polyethylene (LDPE) particles may be present on the surface of th... Class II
Jan 21, 2020 Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, m... Low Density Polyethylene (LDPE) particles may be present on the surface of th... Class II
Nov 12, 2019 ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo... Nonfunctional key due to the potential for damage to the key pins cause by fo... Class II
Oct 1, 2019 Aesculap Sterile disposable fleece drape, Product code: GA414, individually p... Packaging seal integrity not validated resulting in a lack of sterility assur... Class II
Sep 25, 2019 AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual ... Needleholder incorrectly labeled as 200MM when the actual instrument size is ... Class II
Aug 7, 2019 CAIMAN DISP.INSTR.ARTICULAT.D:12/440MM REF: PL731SU- Product Usage: Instrume... possibility of the sterility batch being insufficiently sterilized Class II
Aug 7, 2019 CAIMAN DISP.INSTR.ARTICULAT.D:12/240MM REF: PL730SU - Product Usage: Instrum... possibility of the sterility batch being insufficiently sterilized Class II
Feb 16, 2018 Doyen-Collin Mouth Gag 120MM/ General Instruments The plastic sleeves of the Penis Clamp and Mouth Gag may stick together durin... Class III
Feb 16, 2018 Strauss Penis Clamp 130MM/General Instruments The plastic sleeves of the Penis Clamp and Mouth Gag may stick together durin... Class III
Jan 22, 2018 DS Titanium Ligation Clip Appliers, used in laparoscopic surgery Added a contraindication to IFU: Do not use the DS clips for living donor nep... Class II
Jan 22, 2018 DS Titanium Ligation Clip, used in laparoscopic surgery Added a contraindication to IFU: Do not use the DS clips for living donor nep... Class II
Sep 21, 2017 proSA Tool Set used to adjust and verify the proSA Adjustable Shunt System ... A proSA adjusting pin used to adjust the proSA Adjustable Shunt System does n... Class II
Sep 8, 2017 JS Series SterilContainer S2 System The JS Series SterilContainer S2 System was released to the market place prio... Class II
Sep 5, 2017 ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN 4 1-RING TWIST DRILL D2.0 ... ELAN 4 burr/blade accessories were marketed without 510(k) premarket notifica... Class II
Sep 5, 2017 ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN 4 1-RING ROSEN BURR+ D0.8 ... ELAN 4 burr/blade accessories were marketed without 510(k) premarket notifica... Class II
Sep 5, 2017 ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN 4 1-RING NEURO CUTTER+ SOFT... ELAN 4 burr/blade accessories were marketed without 510(k) premarket notifica... Class II
Sep 1, 2017 The ELAN 4 Air System is intended for high speed cutting, sawing and drilling... The ELAN 4 Air System was released to the market place prior to an authorized... Class II

View all 61 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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