Every recall we track for Aesculap Implant Systems LLC — 51 in all — plus the complaints and injury reports the public filed about them.
Aesculap recalls specific brain ventricle implant systems (product code FF399R) due to trocar shaft length issues that may obscure the visual field when used with certain neuroendoscopes.
Aesculap recalls surgical needles with incorrect product code MD611 instead of MD610. This may cause confusion in medical use. Affected needles have specific model numbers and lot details.
Aesculap recalls its Caiman Articulating D5/360MM surgical device due to risk of spring falling out during procedures, potentially entering the patient's body. Affected units have specific product codes and lot numbers.
Aesculap recalls Caspar Cervical Retractor Basket ME754 and ME764 due to mislabeled GTIN numbers. This affects medical devices used in surgeries. No immediate action needed as the product is safe but must be identified correctly.
Aesculap recalls ENNOVATE sterile set screws for spinal stabilization due to potential incorrect screw inclusion in packages. Affected units include specific lot numbers and article codes.
Aesculap recalls robotic microscopes with software 2.7 or earlier due to application errors causing rebalancing, robot recovery, and autofocus issues. Affected units have specific serial numbers and article numbers.
Aesculap recalls Modulift VBR SZ.M 4MM set screwdriver (MF790R) due to risk of deforming during surgery. Affected units have UDI-DI: 04046964067648. Contact for remedy.
Aesculap recalls LEFT CORONAL BENDER model TEK1939 used in spinal surgery due to potential deformation of implants. Affected units sold with lot number 2930901A.
Aesculap recalls specific spinal surgery instrument (TEK1940) due to risk of implant deformation during spinal procedures. Affected units sold with lot number 2930902A.
Aesculap recalls PAS-PORT Proximal Anastomosis Devices (US Catalog FG-000001-13) due to potential deployment failure requiring additional surgery. Affected devices may need extra medical intervention.
Aesculap recalls PAS-PORT Proximal Anastomosis System (FC700SU) due to potential deployment failure requiring additional surgery. Affected units include all batch codes.
Aesculap recalls Univation X knee implant devices (NL482-NL487) due to potential loosening requiring revision surgery. Affected patients should contact the company for details.
Aesculap recalls Univation X System knee implants (NL488-NL493) due to potential loosening requiring revision surgery. Affected patients should contact the manufacturer for details.
Aesculap recalls specific Univation X System Tray knee implant devices due to potential loosening requiring revision surgery. Affected models include NM1090R Navigation Set and others. Contact for return instructions.
Aesculap recalls specific Univation X System knee implants due to potential loosening requiring revision surgery. Affected models include NL476 to NL481.
Aesculap recalls Univation X System knee implants (models NO180Z to NO189Z) due to potential loosening causing revision surgery. Affected patients should contact the manufacturer for details.
Aesculap recalls specific Univation X System knee implants due to potential loosening that may require revision surgery. Affected models include NL494 to NL499 with 11mm size.
Aesculap recalls Univation X System knee implants (models NO156Z to NO167Z) due to possible loosening requiring revision surgery. Affected patients should contact the manufacturer for details.
Aesculap recalls specific Univation X System knee implants due to possible loosening requiring revision surgery. Affected models include NL470 to NL475 with all lots.
Aesculap recalls Universal Robot UR5 arm (PV010204) for potential robotic arm malfunction causing system restarts. Affected units have specific UDI-DI and serial numbers.
Aesculap recalls ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R) after risk of spinal fixation arm fracture during spinal surgery procedures.
Aesculap recalls S4 Cervical Cross Connectors (SW114T) used in spinal fusion due to potential movement or microparticle abrasion. Affected patients should contact the manufacturer for details.
Aesculap recalls S4 Cervical Cross Connectors (SW112T) used in spinal fusion due to insufficient clamping force, potentially causing movement or microparticle abrasion. Affected patients should contact manufacturer for details.
Aesculap recalls S4 cervical cross connectors used in spinal fusion surgery due to potential movement causing spinal instability. Affected models include S4C CROSS CONNECTOR VARIABLE 28-33MM, SW115T.
Aesculap recalls S4 cervical cross connectors (SW116T) used in spinal fusion surgery due to potential movement or microparticle abrasion. Affected units may require replacement.
Aesculap recalls S4 Cervical Cross Connectors (42-58mm) used in spinal fusion surgery due to potential movement or microparticle abrasion. Affected units have product code SW117T.
Aesculap recalls S4 Cervical Cross Connectors (SWT113T) used in spinal fusion due to potential movement or microparticle abrasion. Affected patients should contact manufacturer for details.
Aesculap recalls ENNOVATE MIS Removal Key Short (SZ380R) due to risk of spinal fixation arm fracture if 90-degree angle not met during use. Affected users should contact for details.
Aesculap recalls Prestige Atraumatic Grasper with port dual action for possible handle separation during endoscopic use. Affected units have specific product codes and lot numbers.
Aesculap recalls Prestige Retraction Graspers with potential handle separation. Affected models include 8361-10 (UDI-DI: 04046955083381) sold in specific lots. Stop using immediately to avoid injury.
Aesculap recalls knee implant components (model nos. NR068K-Z) due to potential LDPE particles in packaging. Affected products may have low-risk contamination but require verification.
Aesculap recalls knee implant components (model nos. NN058Z to NN479Z) due to potential LDPE particles in packaging. Affected products may have particles that could cause complications during surgery.
Aesculap recalls knee implant components (model nos. NN081K-NN089K) due to potential LDPE particles in packaging. Affected products were sold with old packaging configurations before Lot 52533610.
Aesculap recalls knee implant components (model nos. NN469K-NN479K) due to potential LDPE particles in packaging. Affected products may have particles that could cause irritation or infection during surgery.
Aesculap Implant Systems LLC
Aesculap recalls Enduro Special Key Tib Lock Ring F1/10mm (product code NP462R) used in knee surgery due to potential key pin damage during assembly. Affected items sold with EnduRo Total Knee System.
Aesculap recalls sterile disposable fleece drapes (product code GA414) due to unverified packaging seals risking contamination. Affected units include specific lot numbers and shipping units.
Aesculap recalls a surgical needle holder labeled as 200mm but actually 150mm. This size error may cause improper use during procedures. Affected units have product code MG524R.
Aesculap recalls CAIMAN surgical instruments due to potential insufficient sterilization in batch 823B. This may affect instruments used in general and gynecologic surgery. Contact for remedy details.
Aesculap recalls specific surgical instruments due to potential insufficient sterilization in certain batches. Affected instruments may pose infection risks during procedures.
Aesculap recalls Doyen-Collin Mouth Gag 120MM (OM040R) due to plastic sleeves sticking together after reprocessing, making instruments unusable. Affected users should contact the manufacturer for details.
Aesculap recalls Strauss Penis Clamp 130MM/General Instruments due to plastic sleeves sticking during reprocessing, making instruments unusable after reprocessing. Affected units include model EF401R.
Aesculap recalls DS Titanium Ligation Clip Appliers used in laparoscopic surgery for living donor nephrectomies. Updated instructions add contraindications to prevent misuse.
Aesculap recalls DS Titanium Ligation Clips used in laparoscopic surgery for living donor kidney transplants. The clips were not approved for this use per 2017 publication.
