Reported Apr 8, 2015 · Terminated
Vitagel; indicated in surgical procedures (other than in neurosurgical and ophthalmic) as an adjunct to hemostasis when…
Orthovita, Inc., dba Stryker Orthobiologics.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthovita, Inc., dBA Stryker Orthobiologics. · 45 Great Valley Pkwy · Malvern, PA · 19355-1302
Is this the product you have?
- 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.
- Lot codes and dates
3 of 3 products
Products covered by this recall # Product as published 1 2113-0000, 2113-0202 , 2113-0205 2 Lot Numbers: A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076 3 Expiry Dates: 02/28/2017, 08/31/2016, 03/31/2017, 10/31/2016, 10/31/2016, 01/31/2017, 09/30/2016 - Amount recalled
- 274
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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