The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1353-2015·Announced 2015-04-08

Stryker Recalls Vitagel Surgical Hemostat Due to Cold Chain Violations

Stryker Orthobiologics is recalling Vitagel surgical hemostat shipments that were not delivered within validated timeframes, potentially compromising the product's required cold storage.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a cold chain violation without reporting any specific illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.

Plain-English summary

Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 274 units of Vitagel, a surgical hemostat indicated as an adjunct to hemostasis in surgical procedures. The recall involves specific product numbers (2113-0000, 2113-0202, 2113-0205) and lot numbers (A1407061, A1406053, A1410055, A1501033, A1407037, A1412010, A1412076) with expiry dates ranging from August 2016 to March 2017.

The recall was initiated because several shipments of Vitagel, which requires storage at 2 to 8 degrees Celsius, were not delivered to customers within the validated delivery time. This deviation from the required cold chain may affect the product's integrity. The affected units were distributed nationwide, including in New York, Pennsylvania, West Virginia, Michigan, Illinois, Massachusetts, Texas, Arkansas, Kansas, Florida, Wisconsin, California, Missouri, Louisiana, Virginia, Iowa, Ohio, and North Carolina.

Healthcare facilities and distributors should stop using the affected Vitagel units and contact the recalling firm for instructions on return or disposal. Consumers are not directly affected as this is a professional medical device used in surgical settings.

The recalled product

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.
Manufacturer
Orthovita, Inc., dBA Stryker Orthobiologics.
Category
Medical Device — Surgical Hemostasis
Hazard
Affected units
274

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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
  • 01/31/2017
  • 09/30/2016

Distribution

Distributed nationwide across the United States.

The notice also names 18 states specifically:

Related recalls

Same manufacturer · Orthovita, Inc., dBA Stryker Orthobiologics.

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