Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects
Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential breach of sterile packaging which poses a risk of harm (infection) to patients, even though no injuries have been reported.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 9,805 units of the Aliquot Delivery Kit (Syringe and Plunger). This medical device is used in open and percutaneous procedures to facilitate the placement of bone cement in weakened or diminished bone. The recall affects all lots of model numbers 2090-0501, 2090-0502, 2090-0504, and 2090-0505.
The recall was initiated after two isolated instances of holes were identified in the outer header bag component of the double barrier sterile packaging configuration. These defects could potentially compromise the sterile barrier, posing a risk of infection if the device is used.
The affected devices were distributed nationwide and in the following countries: Australia, Belgium, Denmark, France, Germany, Italy, Malta, Netherlands, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Affected units
- 9,805
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 (5)
- All lots
- Model Number of device: 2090-0501
- 2090-0502
- 2090-0504
- 2090-0505
Distribution
Distributed nationwide across the United States.
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