Z-1353-2015Class II

Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to...

Name: Z-1353-2015 Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to...
Creator: Orthovita, Inc., dBA Stryker Orthobiologics.
Published: 2015-02-26
License: https://open.fda.gov/license/

DSM Biomedical, Inc. / initiated 2015-02-26 / Terminated

FDA source

Orthovita, Inc., dBA Stryker Orthobiologics. began a recall of Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or... on 2015-02-26. FDA classified it as Class II and gives the reason as "Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1353-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Posted: 2015-03-30
Terminated: 2015-07-28
Recalling firm: DSM Biomedical, Inc.
Product: Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
Product code: LMH Implant, Dermal, For Aesthetic Use
Reason for recall: Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees Celsius (C) were not delivered to customers within the validated delivery time.
FDA root cause: Storage
Action: Orthovita, Inc., dBA Stryker Orthobiiologics made phone notifications in February 2015 to all affected customers. Customers were told that the Vitagel they ordered on x date has an internal procedural mandate that says they must deliver in 35 hours and it has now passed that window. As a precaution until we can confirm that Vitagel delivered after shipping for longer is safe for use we are asking that they quarantine the order in question in the event the delivery occurs. For questions regarding this recall call 610-640-1775.
Quantity in commerce: 274
Distribution: Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
Product codes and lots: Product Numbers: 2113-0000, 2113-0202 , 2113-0205; Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076; Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1353-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1353-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-03-30

Product code LMH

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)