Smith & Nephew, Inc. Endoscopy Division

FDA Regulatory Profile

Summary

Total Recalls
37
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Known Names

smith and nephew inc., endoscopy division, smith and nephew, inc. endoscopy division

Recent Recalls

NumberClassProductDate
Z-2046-2014Class IISUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Cobraid Suture Product Code: 72203842 FasteneJune 2, 2014
Z-2045-2014Class IISUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixatJune 2, 2014
Z-2047-2014Class IISUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegrJune 2, 2014
Z-2048-2014Class IISUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixaJune 2, 2014
Z-2049-2014Class IISUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable,June 2, 2014
Z-2216-2013Class IIBIORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture; Part Number: 72200774 Biodegradable sutuAugust 6, 2013
Z-2236-2013Class IITWINFIX Ultra PLLA/HA 6.5 mm with 3 ULTRABRAID Suture; Part Number: 72202610 Biodegradable sutureAugust 6, 2013
Z-2227-2013Class IIOSTEORAPTOR CURVED 2.3 mm Suture Anchor ULTRABRAID COBRAID Suture, Black; Part Number: 72203291 August 6, 2013
Z-2218-2013Class IIBIORAPTOR 2.9 mm Suture Anchor Straight, pack of 2 ULTRABRAID Suture; Part Number: 72200690 BiodeAugust 6, 2013
Z-2233-2013Class IITWINFIX Ultra PLLA/HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black: Part Number: 722August 6, 2013
Z-2240-2013Class IITWINFIX Ultra 6.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with August 6, 2013
Z-2225-2013Class IIOSTEORAPTOR 2.9 mm Suture Anchor with 2 ULTRABRAID Suture, White / Black; Part Number: 72201996 August 6, 2013
Z-2223-2013Class IIOSTEORAPTOR 2.3 mm Suture Anchor with 1 ULTRABRAID COBRAID Suture, Black; Part Number: 72201992 August 6, 2013
Z-2226-2013Class IIOSTEORAPTOR 2.9 mm Suture Anchor with 1 ULTRABRAID Suture, White; Part Number: 72202165 BiodegrAugust 6, 2013
Z-2231-2013Class IITWINFIX Ultra HA 5.5 mm Suture Anchor with 2 ULTRABRAID Suture, Blue / Black; Part Number: 72202626August 6, 2013
Z-2222-2013Class IIOSTEORAPTOR 2.3 mm with 1 ULTRABRAID Suture, White; Part Number: 72201991 Biodegradable suture aAugust 6, 2013
Z-2238-2013Class IITWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID") witAugust 6, 2013
Z-2220-2013Class IIOSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture, Blue; Part Number: 72201993 BiAugust 6, 2013
Z-2237-2013Class IIRAPTORMITE" 3.7 mm PLLA with two ULTRABRAID" Sutures Size 0 and Needles; Part Number: 72201805 BiAugust 6, 2013
Z-2239-2013Class IITWINFIX Ultra 5.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue, blue-COBRAID) with August 6, 2013