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Smith & Nephew, Inc.

290 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
4.8 MM X 1.8 MM DRILL FOR HA COATED HALF PINS, CANNULATED, REF 71070845, QTY: (1), STERILE recall (Z-1708-2012)Smith & Nephew Inc2012-06-06
2.0 MM X 191 MM DRILL, REF 71173802, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, T recall (Z-1709-2012)Smith & Nephew Inc2012-06-06
2.7 MM X 191 MM DRILL, REF 71173804, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, T recall (Z-1710-2012)Smith & Nephew Inc2012-06-06
3.5 MM X 191 MM DRILL, REF 71173806, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, T recall (Z-1711-2012)Smith & Nephew Inc2012-06-06
3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71751149, QTY: (1), STERILE R, Smith & Nephew, recall (Z-1712-2012)Smith & Nephew Inc2012-06-06
3.2 MM LONG GRADUATED BRAD POINT DRILL, REF 71780105, QTY: (1), STERILE R, Smith & Nephew, recall (Z-1713-2012)Smith & Nephew Inc2012-06-06
3.2 MM IMHS(R) CP SHORT BRAD POINT DRILL, REF 71687001, QTY: (1), STERILE R, Smith & Nephe recall (Z-1714-2012)Smith & Nephew Inc2012-06-06
2.0 MM DRILL BIT, REF 71173501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 381 recall (Z-1715-2012)Smith & Nephew Inc2012-06-06
2.7 MM DRILL BIT, REF 71173503, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 381 recall (Z-1716-2012)Smith & Nephew Inc2012-06-06
3.2 MM TROCAR, REF 71751136, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 recall (Z-1717-2012)Smith & Nephew Inc2012-06-06
6.5 MM CANELLOUS TAP W/ QUICK CONNECT, REF 71173509, QTY: (1), STERILE R, Smith & Nephew, recall (Z-1718-2012)Smith & Nephew Inc2012-06-06
PERI-LOC(R) TARGETER 2.7 MM PF PIN 18 MM, SST, REF 71173438, QTY: (1), STERILE R, Smith & recall (Z-1719-2012)Smith & Nephew Inc2012-06-06
PERI-LOC(R) TARGETER 2.7 MM PF PIN 40 MM, SST, REF 71173406, QTY: (1), STERILE R, Smith & recall (Z-1720-2012)Smith & Nephew Inc2012-06-06
PELVIS PIN, REF 71366302, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 Ort recall (Z-1721-2012)Smith & Nephew Inc2012-06-06
ACETABULAR PIN, REF 71366301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116 recall (Z-1722-2012)Smith & Nephew Inc2012-06-06
SMALL JOYSTICK THREADED PIN, REF 71173396, QTY: (1), STERILE R, Smith & Nephew, Inc., Memp recall (Z-1723-2012)Smith & Nephew Inc2012-06-06
LARGE JOYSTICK THREADED PIN, REF 71173339, QTY: (1), STERILE R, Smith & Nephew, Inc., Memp recall (Z-1724-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 10 MM X 150 MM HA COATED HALF PIN SST, REF 71070823, QTY: (1), STERILE R, Smith & recall (Z-1725-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070824, QTY: (1), STERILE R, Smith & recall (Z-1726-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070825, QTY: (1), STERILE R, Smith & recall (Z-1727-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070826, QTY: (1), STERILE R, Smith & recall (Z-1728-2012)Smith & Nephew Inc2012-06-06
4.5 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070827, QTY: (1), STERILE R, Smith & recall (Z-1729-2012)Smith & Nephew Inc2012-06-06
6 MM X 15 MM X 150 MM HA COATED HALF PIN SST, REF 71070828, QTY: (1), STERILE R, Smith & N recall (Z-1730-2012)Smith & Nephew Inc2012-06-06
6 MM X 20 MM X 150 MM HA COATED HALF PIN SST, REF 71070800, QTY: (1), STERILE R, Smith & N recall (Z-1731-2012)Smith & Nephew Inc2012-06-06
6 MM X 25 MM X 150 MM HA COATED HALF PIN SST, REF 71070802, QTY: (1), STERILE R, Smith & N recall (Z-1732-2012)Smith & Nephew Inc2012-06-06
6 MM X 30 MM X 150 MM HA COATED HALF PIN SST, REF 71070804, QTY: (1), STERILE R, Smith & N recall (Z-1733-2012)Smith & Nephew Inc2012-06-06
6 MM X 35 MM X 150 MM HA COATED HALF PIN SST, REF 71070806, QTY: (1), STERILE R, Smith & N recall (Z-1734-2012)Smith & Nephew Inc2012-06-06
6 MM X 40 MM X 150 MM HA COATED HALF PIN SST, REF 71070808, QTY: (1), STERILE R, Smith & N recall (Z-1735-2012)Smith & Nephew Inc2012-06-06
6 MM X 45 MM X 150 MM HA COATED HALF PIN SST, REF 71070835, QTY: (1), STERILE R, Smith & N recall (Z-1736-2012)Smith & Nephew Inc2012-06-06
6 MM X 50 MM X 150 MM HA COATED HALF PIN, 1.6 MM CANNULATED, SST, REF 71070822, QTY: (1), recall (Z-1737-2012)Smith & Nephew Inc2012-06-06
6 MM X 50 MM X 150 MM HA COATED HALF PIN SST, REF 71070810, QTY: (1), STERILE R, Smith & N recall (Z-1738-2012)Smith & Nephew Inc2012-06-06
6 MM X 55 MM X 150 MM HA COATED HALF PIN SST, REF 71070812, QTY: (1), STERILE R, Smith & N recall (Z-1739-2012)Smith & Nephew Inc2012-06-06
6 MM X 60 MM X 150 MM HA COATED HALF PIN SST, REF 71070814, QTY: (1), STERILE R, Smith & N recall (Z-1740-2012)Smith & Nephew Inc2012-06-06
6 MM X 65 MM X 150 MM HA COATED HALF PIN SST, REF 71070816, QTY: (1), STERILE R, Smith & N recall (Z-1741-2012)Smith & Nephew Inc2012-06-06
6 MM X 70 MM X 150 MM HA COATED HALF PIN SST, REF 71070818, QTY: (1), STERILE R, Smith & N recall (Z-1742-2012)Smith & Nephew Inc2012-06-06
6 MM X 20 MM X 200 MM HA COATED HALF PIN SST, REF 71070801, QTY: (1), STERILE R, Smith & N recall (Z-1743-2012)Smith & Nephew Inc2012-06-06
6 MM X 25 MM X 200 MM HA COATED HALF PIN SST, REF 71070803, QTY: (1), STERILE R, Smith & N recall (Z-1744-2012)Smith & Nephew Inc2012-06-06
6 MM X 30 MM X 200 MM HA COATED HALF PIN SST, REF 71070805, QTY: (1), STERILE R, Smith & N recall (Z-1745-2012)Smith & Nephew Inc2012-06-06
6 MM X 35 MM X 200 MM HA COATED HALF PIN SST, REF 71070807, QTY: (1), STERILE R, Smith & N recall (Z-1746-2012)Smith & Nephew Inc2012-06-06
JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, recall (Z-1747-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & recall (Z-1748-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & recall (Z-1749-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & recall (Z-1750-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & recall (Z-1751-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, QTY: (1), STERILE R, Smith & recall (Z-1752-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & recall (Z-1753-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & recall (Z-1754-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & recall (Z-1755-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & recall (Z-1756-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V, REF 71056658, QTY: (1), STERILE R, Smith & recall (Z-1757-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, QTY: (1), STERILE R, Smith & recall (Z-1758-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71055201, QTY: (1), STERILE R, Smith & recall (Z-1759-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71055251, QTY: (1), STERILE R, Smith & recall (Z-1760-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71055301, QTY: (1), STERILE R, Smith & recall (Z-1761-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, QTY: (1), STERILE R, Smith & recall (Z-1762-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71055401, QTY: (1), STERILE R, Smith & recall (Z-1763-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71055501, QTY: (1), STERILE R, Smith & recall (Z-1764-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71055551, QTY: (1), STERILE R, Smith & recall (Z-1765-2012)Smith & Nephew Inc2012-06-06
JET-X(R) 5 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71055701, QTY: (1), STERILE R, Smith & recall (Z-1766-2012)Smith & Nephew Inc2012-06-06
5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932948, recall (Z-1767-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932951, recall (Z-1768-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932952, recall (Z-1769-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932953, recall (Z-1770-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932961, recall (Z-1771-2012)Smith & Nephew Inc2012-06-06
6.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932962, recall (Z-1772-2012)Smith & Nephew Inc2012-06-06
***REF 66800694***Qty 10***smith&nephew***RENASYS Port Foam Dressing Kit Port***STERILE*** recall (Z-0875-2012)Smith & Nephew Inc.2012-01-26
smith&nephew NO-STING SKIN-PREP No-Sting Protective Wipes Effective protection between tap recall (Z-2748-2011)Smith & Nephew Inc.2011-07-06
BRAND: SKIN-PREP - Pouch Labeling and Box / Carton Labeling ***smith&nephew ***#420400***S recall (Z-2749-2011)Smith & Nephew Inc.2011-07-06
Brand: UNI-SOLVE Adhesive Remover Wipe Pouch, 50 Count Box Label ***smith&nephew***#402300 recall (Z-2750-2011)Smith & Nephew Inc.2011-07-06
Brand REMOVE Universal Adhesive Remover Wipe - Pouch Label and 50 count box Label: ***smit recall (Z-2751-2011)Smith & Nephew Inc.2011-07-06
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE recall (Z-2053-2011)Smith & Nephew Inc2011-04-22
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE recall (Z-2054-2011)Smith & Nephew Inc2011-04-22
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE recall (Z-2055-2011)Smith & Nephew Inc2011-04-22
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE recall (Z-2056-2011)Smith & Nephew Inc2011-04-22
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE recall (Z-2057-2011)Smith & Nephew Inc2011-04-22
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE recall (Z-2058-2011)Smith & Nephew Inc2011-04-22
smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma L recall (Z-0411-2011)Smith & Nephew Inc2010-11-18
smith&nephew EZCARE Negative Pressure Rx only. 100-240 V 12 V 50/60 Hz 90VA T1A 250 V Indi recall (Z-0310-2011)Smith & Nephew Inc.2010-11-03
R3 (TM) 22 MM I.D., 52 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339152, recall (Z-0079-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 22 MM I.D., 54 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339154, recall (Z-0080-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 22 MM I.D., 56 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339156, recall (Z-0081-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 22 MM I.D., 58 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339158, recall (Z-0082-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, recall (Z-0083-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 28 MM I.D., 62 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339162, recall (Z-0084-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 28 MM I.D., 64 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339164, recall (Z-0085-2011)Smith & Nephew Inc2010-10-18
R3 (TM) 28 MM I.D., 66/70 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 713391 recall (Z-0086-2011)Smith & Nephew Inc2010-10-18
PERI-LOC (R), 3.5 MM ANTEROLATERAL DISTAL TIBIA PLATE, 10 HOLE, RIGHT - 148 MM, REF 718007 recall (Z-2314-2010)Smith & Nephew Inc2010-08-31
CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008 recall (Z-2197-2010)Smith & Nephew Inc2010-08-10
CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE 008 recall (Z-2198-2010)Smith & Nephew Inc2010-08-10
PERI-LOC, 2.0 MM X 228 MM, K-WIRE W/TROCAR POINT, CO-CR, REF 71173361, QTY: (6), STERILE F recall (Z-2199-2010)Smith & Nephew Inc2010-08-10
GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew recall (Z-1900-2010)Smith & Nephew Inc2010-06-24
PROMOS Inclination set, SIZE 20mm, REF 42 180, S&N 75006722, QTY: (1), STERILE R, Smith & recall (Z-1239-2010)Smith & Nephew Inc2010-04-07
PROMOS Inclination set, SIZE 22mm, REF 42 182, S&N 75006723, QTY: (1), STERILE R, Smith & recall (Z-1240-2010)Smith & Nephew Inc2010-04-07
PROMOS Inclination set, SIZE 24mm, REF 42 184, S&N 75006724, QTY: (1), STERILE R, Smith & recall (Z-1241-2010)Smith & Nephew Inc2010-04-07
PROMOS Inclination set, SIZE 26mm, REF 42 186, S&N 75006725, QTY: (1), STERILE R, Smith & recall (Z-1242-2010)Smith & Nephew Inc2010-04-07
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDICAL/TIGHT LATERAL, A/P 38 MM, M/L 24 MM, REF 7142 recall (Z-0924-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422 recall (Z-0925-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 46MM, M/L 27 MM, REF 714222 recall (Z-0926-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 49 MM, M/L 29 MM, REF 71422 recall (Z-0927-2010)Smith & Nephew Inc2010-03-03
JOURNEY " UNI TIBIAL BASEPLATE, LEFT MEDIAL/RIGHT LATERAL, A/P 52 MM, M/L 30 MM, REF 71422 recall (Z-0928-2010)Smith & Nephew Inc2010-03-03
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Every clearance here is in the API, with alerts when new ones post.