FDA Medical Device Recalls (openFDA)
Orthovita, Inc., dBA Stryker Orthobiologics.: 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.
- Recall number
- Z-1353-2015
- Recalling firm
- Orthovita, Inc., dBA Stryker Orthobiologics.
- 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.
- Status
- Terminated
- Initiated
- 2015-02-26
- Posted
- 2015-03-30
- Terminated
- 2015-07-28
- Reason
- 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.
- 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
- 274
- Distribution
- Nationwide Distribution including NY PA WV MI IL MA TX AR KS FL WI CA MO LA VA IA OH and NC.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P050044"]
- Product code
- LMH
- Firm FEI
- 1000307073
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28