Smith & Nephew Endoscopy, Inc.
United StatesFDA applicant, unverified
- Devices
- 28
- FDA recalls
- 12
At a glance
Market reach
- United States
- FDA recalls
What Smith & Nephew Endoscopy, Inc. makes
The company manufactures orthopedic and endoscopic devices, including knotless soft-tissue anchors for ligament repair, minimally invasive surgery (MIS) instruments, and suture management systems like suture locks, collets, and anchors. It also produces surgical kits for meniscus repair, such as the Acufex Mosaicplasty System, along with interference screws and tibial anchors for joint stabilization. Fluid management systems for surgical procedures are part of its portfolio, alongside specialized screws for bone fixation.
These devices are regulated under FDA 510(k) clearance, with most classified as Class I or Class II medical devices. The company’s products are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Search and filter all 28 devicesFDA recalls
2015
- 10 Sep 2015 Z-0155-2016 Class II Terminated Sterility of device is compromised due to breach in the packaging
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- 10 Sep 2015 Z-0156-2016 Class II Terminated Sterility of device is compromised due to breach in the packaging
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- 10 Sep 2015 Z-0157-2016 Class II Terminated Sterility of device is compromised due to breach in the packaging
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- 10 Sep 2015 Z-0158-2016 Class II Terminated Sterility of device is compromised due to breach in the packaging
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- 10 Sep 2015 Z-0155-2016 Class II Terminated Sterility of device is compromised due to breach in the packaging
2013
- 30 Jul 2013 Z-0818-2016 Class II Terminated During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
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- 4 Apr 2013 Z-0699-2016 Class II Terminated Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
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- 4 Apr 2013 Z-0700-2016 Class II Terminated Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
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- 30 Jul 2013 Z-0818-2016 Class II Terminated During arthroscopic surgery, when the scope is moved inside the cannula, the body of the irrigation extender separates, potentially obstructing visualization and causing leakage of the irrigation fluid. The device is removed and a back-up device is used to complete the surgery.
2009
- 3 Sep 2009 Z-0415-2010 Unclassified (pre-2012) Terminated Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
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- 3 Sep 2009 Z-0416-2010 Unclassified (pre-2012) Terminated Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
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- 3 Sep 2009 Z-0417-2010 Unclassified (pre-2012) Terminated Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
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- 3 Sep 2009 Z-0415-2010 Unclassified (pre-2012) Terminated Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
Show all 12 recalls
2005
- 1 Jul 2005 Z-0371-06 Unclassified (pre-2012) Terminated Drill does not contain laser etched depth marks to assure proper depth of inserted device
- 6 Apr 2005 Z-0973-05 Unclassified (pre-2012) Terminated Cupped Grasper Handle marked incorrectly as Duckbill Upbiter
Frequently asked questions
How many devices does Smith & Nephew Endoscopy, Inc. have in the registry?
The registry currently lists 28 devices for Smith & Nephew Endoscopy, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smith & Nephew Endoscopy, Inc.'s devices?
Among its 28 most recently registered devices, Smith & Nephew Endoscopy, Inc. has devices listed in FDA 510(k) (28 devices).
What risk classes do Smith & Nephew Endoscopy, Inc.'s devices fall under?
Among its 28 most recently registered devices, the classes recorded for Smith & Nephew Endoscopy, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Smith & Nephew Endoscopy, Inc.?
FDA recall records list 12 recalls initiated by Smith & Nephew Endoscopy, Inc., the most recent initiated on 10 Sep 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Smith & Nephew Endoscopy, Inc. in the registry?
The most recently registered devices listed for Smith & Nephew Endoscopy, Inc. include PLLA, HA SCREW, SMITH & NEPHEW KNOTLESS INSTABILITY ANCHOR, BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM, 10MM, 12MM and REGENETEN™ Bioinductive Implant.