Device Recall Natrelle

Serial No. (Lot No.) 11250691 (1030868), 11514564 (1107468), 11560447 (1120606), 14410441 (1745182), 14460177 (1752996), 14651643 (1782042), 14645258 (1781272), 14418851 (1747035), 14663483 (1784601), 14768174 (1800575), 11650852 (1146235), 11759596 (1175538), 11783801 (1181003), PX1195 (583159), VB9805 (1-116051), PG1537 (567007), PH8804 (569489), PK3108 (570078), PK3369 (570134), PK3381 (570134), PK6626 (570491), PK8403 (570651), PL0978 (570658), PL8893 (571285), PM0276 (571744), PM0279 (571744), PM1034 (571785), PM1035 (571785), PR2461 (575450), PU9968 (579552), PW3583 (581746), PY7600 (585517), QA8130 (592961), QD5894 (619680), NX6700 (559633), QE7679 (620372), 11267520 (1034755), QF7608 (620772), QF7606 (620772), QF9587 (621060), QJ6913 (622768), QP0282 (624977), NW1978 (558962), UM5622 (612529A), PK3255 (569968), PK3423 (570136), PK7369 (570539), PP0932 (574053), PR2462 (575450), QF9588 (621060), 11372224 (1076904), 11397846 (1080914), PT8307 (577871), PT8312 (577871), PU3940 (578909), PV9233 (581160), PV9228 (581160), PW8262 (582676), PW8276 (582676), PW3563 (581746), UM3161 (612983), UP7183 (614339), UP7173 (614339), QF7615 (620772), QG7571 (621426), 11237155 (1029108), NX9778 (559999), PN4372 (573203), PA0253 (561356), PW3861 (581836), PW8259 (582676), UN3074 (613518), PG1546 (567007), UW7921 (617765), 11200803 (1001347), 11201052 (1001668), 11206048 (1004514), 11206049 (1004514), 11206681 (1006447), 11250680 (1030868), 11250702 (1030871), 11514565 (1107468), 11250734 (1030876), 11263982 (1034109), 11269159 (1035181), 11269154 (1035181), 11284363 (1038784), 11307159 (1046470), 11348914 (1067365), 11346491 (1068038), 11367799 (1076435), 11406083 (1088212), 11406084 (1088212), 11406085 (1088212), 11424452 (1091673), 11637421 (1129216), 11718948 (1164435), 11729830 (1165720), 11739519 (1171269), 11759602 (1175538), 12477973 (1383846), 12477975 (1383846), 12495792 (1387445), 12567989 (1402594), 13098492 (1513910), 13098502 (1513910), 11247636 (1030431), 11254038 (1031312), 11368096 (1075819), 11458035 (1097974), 11458039 (1097974), 11458341 (1098680), 11478944 (1102774), 11347486 (1067367).

General and Plastic Surgery Devices

Unclassified

Yes

US in the state of Canada

Natrelle 133 Series Tissue Expanders || Product Usage: || Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed.

Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM).

General and Plastic Surgery Devices

Unclassified

Yes

US in the state of Canada

Natrelle CUI Series Tissue Expanders. || Product Usage: || Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port.