Z-2283-2016Class II

Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating...

Name: Z-2283-2016 Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating...
Creator: LeMaitre Vascular, Inc.
Published: 2016-06-22
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2016-06-22 / Terminated

FDA source

LeMaitre Vascular, Inc. began a recall of Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium... on 2016-06-22. FDA classified it as Class II and gives the reason as "US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2283-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-22
Posted: 2016-07-25
Terminated: 2021-04-08
Recalling firm: LeMaitre Vascular Inc.
Product: Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an accessory to the Anastoclip AC Clip Applier.
Product code: FZP Clip, Implantable
Reason for recall: US marketing brochure for the AnastoClip AC Closure System states that the Anastoclip catalog numbers can be used for dura closure, but the catalog numbers are only intended for cardiovascular use
FDA root cause: Unknown/Undetermined by firm
Action: The firm, LeMaitre Vascular, Inc., sent an "URGENT: Medical Device Correction" letter dated June 20, 2016 to its distributors and hospitals via Priority mail. The letter describes the product, problem and actions to be taken. The customers were informed of the intended use of the devices and the correct catalog numbers to order for the dura application. The customers were instructed to return unused devices for an exchange or refund; destroy any Anastoclip related marketing materials that you have received from Lemaitre between October 25- 2015 and June 15, 2016, and complete and return the reply form for reconciliation of this recall via fax at 781-221-2223, email: [email protected] or by mail. LeMaitre Vascular, Inc. will replace any affected device with a new device labeled for dura closure or issue a credit per request. Questions concerning this safety notice, please contact me at 781-221-2266 ext. 183.
Quantity in commerce: 256 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: ANC1532¿ ANC1577¿ ANC1643¿ ANC1647¿ ANC1673¿ ANC2007¿ ANC2025¿ ANC2027¿ ANC2031¿ ANC2032¿ ANC2037¿

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2283-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2283-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25
Z-2284-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25
Z-2285-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25
Z-2286-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25
Z-2287-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25
Z-2288-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25
Z-2289-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-25

Product code FZP

K962043Class IIAuto Suture Modified Vcs Clip ApplierUnited States Surgical, A Division of Tyco Healthc / cleared 1996-09-23

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)