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 |
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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