Integra Lifesciences Sales LLC
Princeton, NJ, US
INTEGRA LIFESCIENCES SALES LLC appears in FDA device records in Princeton, NJ. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Integra Lifesciences Sales LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Integra Limitedenforcement report, recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001700044 | 3001700044 | INTEGRA LIFESCIENCES SALES LLC | 1100 Campus Rd, Princeton, NJ 08540 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0691-2020 | Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis. | Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant | Class II | Terminated | |
| Z-1338-2019 | Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use. | Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months | Class II | Terminated | |
| Z-1091-2019 | Integra bioBLOCK Resorbable subtaler Implant, 12mm Catalog Number: 040012 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot. | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110F | Class II | Terminated | |
| Z-1090-2019 | Integra bioBLOCK Resorbable subtaler Implant, 11mm Catalog Number: 040011 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot. | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110F | Class II | Terminated | |
| Z-1089-2019 | Integra bioBLOCK Resorbable subtaler Implant, 10mm Catalog Number: 40010 - Product Usage: The bioBLOCK Implant is indicated for internal support to primary surgical interventions in the treatment of flatfoot. | Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110F | Class II | Terminated | |
| Z-0117-2014 | Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature. The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space. The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring. The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage. The Camino 110-4L catheter is intended for use with the Licox Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. | Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. | Class II | Terminated | |
| Z-2056-2013 | Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery. | As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases. | Class II | Terminated | |
| Z-2458-2012 | The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD system. The Left and Right Pads are mirror images. | An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl | Class II | Terminated | |
| Z-2457-2012 | The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The Gel Pads are supplied to users in labeled plastic bags, 1 per bag. Product Usage: The MAYFIELD Horseshoe Gel Pads are used in conjunction with the MAYFIELD Base Units and MAYFIELD Swivel Adaptors for neurosurgeries in the prone or supine positions. They are plastic gel filled devices that provide cushioning between the head and other metallic part of the MAYFIELD system. The Left and Right Pads are mirror images. | An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice versa. None of the complaints resulted in a report of patient injuries or an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that there is no potential harm to patients, onl | Class II | Terminated | |
| Z-2028-2012 | Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon. | The Integra(TM) Jarit(R) Take-Apart Laparoscopic Instrument shafts were released with internal component out of specification. | Class II | Terminated | |
| Z-2585-2011 | Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable. including Neurosurgery. Gastrointestinal and affiliated organ surgery. Urological surgery. Plastic and Reconstructive surgery. General surgery, Orthopedic surgery. Gynecological surgery, Thoracic surgery. laparoscopic surgery and Thoracoscopic surgery. | The insulated covering of a wire cable that powers the vacuum pump in the CUSA NXT Service Module can become abraded over time resulting in the exposure of bare wire. If this bare wire were to come in contact with the metal surface of the pump, it could result in a short circuit and a loss of aspiration. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain