Z-2103-2015Class II

Natrelle 133 Series Tissue Expanders

Name: Z-2103-2015 Natrelle 133 Series Tissue Expanders
Creator: Allergan Inc
Published: 2015-06-18
License: https://open.fda.gov/license/

Allergan / initiated 2015-06-18 / Terminated

FDA source

Allergan Inc began a recall of Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require... on 2015-06-18. FDA classified it as Class II and gives the reason as "Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2103-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-18
Posted: 2015-07-18
Terminated: 2015-12-16
Recalling firm: Allergan
Product: 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.
Product code: LCJ Tissue Expander And Accessories
Reason for recall: Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life.
FDA root cause: Incorrect or no expiration date
Action: A recall letter will be sent on 6/18/15 to all customers who received the NATRELLE 133 and CUI series tissue expanders. The letter provides the problem identified and the action to be taken. Customers are instructed to contact GENCO Pharmaceutical Services if the recall actions on the recall letter are unclear. For product returns, customers are instructed to contact GENCO at (877) 319-8966, 7am to 5pm CST. Customers with credit/reimbursements are instructed to contact Allergan at (800) 811-4148, 7am to 5pm PST. Customers with medical inquiries are instructed to contact (800) 433-8871, option 2, 8am-5pm, PST. Customers with adverse events/product complaints are instructed to call (800) 624-4261, option 3, 8am-5pm CST.
Quantity in commerce: 167 units total (114 units in US)
Distribution: US in the state of Canada
Product codes and lots: 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).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2103-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2103-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17
Z-2104-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-17

Product code LCJ

K862203UnclassifiedMcghan Magna-Site(tm) Tissue ExpanderMcghan Medical Corp. / cleared 1986-07-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)