Z-1289-2013Class II

Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than...

Name: Z-1289-2013 Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than...
Creator: Integra LifeSciences Corporation
Published: 2013-03-28
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2013-03-28 / Terminated / root cause: manufacturing process

FDA source

Integra LifeSciences Corporation began a recall of Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct... on 2013-03-28. FDA classified it as Class II and gives the reason as "Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1289-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-28
Posted: 2013-05-10
Terminated: 2015-06-03
Recalling firm: Integra LifeSciences Corporation
Product: Helistat Absorbable Hemostatic,Collagen Based Helistat is indicated in surgical procedures (other than ophthalmological and urological surgery) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Product code: LMF Agent, Absorbable Hemostatic, Collagen Based
Reason for recall: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, Integra, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 9, 2013, to all US, Canada, and non-EU Integra consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to verify if they have any lots of the listed product, if so, STOP using that product; remove the product from service; and promptly complete and return the PRODUCT RECALL RETURN ACKNOWLEDGMENT FORM via Email: [email protected] or FAX to : 1-609-275-9445. Customer Service department will contact you to return and replace the product. "However, if you have already implanted or used collagen sponge products affected by this recall, we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol." For assistance or any other questions that you may have, please contact Customer Service at 1-855-532-1723.
Quantity in commerce: 24,342 boxes
Distribution: Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Arab Emirates, Argentina, Belgium, Brasil, Canada, Chile, China, Costa Rica, Denmark, Egypt, Spain, France, Great Britain, Italy, Japan, Peru, Singapore, Thailand, and South Africa.
Product codes and lots: 1104789 1104790, 1110793 1112248, 1110248 1111867

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1289-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1282-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1283-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1284-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1285-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1286-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1287-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1288-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1289-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1290-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1291-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1292-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1293-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1294-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1295-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1296-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1297-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1298-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1299-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1300-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1301-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10
Z-1302-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-10

Product code LMF

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)