Stryker Orthobiologics Aliquot Delivery System Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 155 units of the Aliquot Syringe Delivery System because the catheter may break during removal from the needle.
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 agency classified this as a Class II recall, and the source text explicitly attributes the hazard to use errors with a corrective action limited to documentation revision, fitting the criteria for moderate severity.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 155 units of the Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument, specifically the 6-inch Aliquot Syringe Delivery System (Part Number 2090-0504). The affected units are identified by Lot Numbers A1006026 and A1111020. The product is used to facilitate the placement of bone cement in weakened or diminished bone.
The recall was initiated due to reported cases of the catheter breaking when removed from the needle during vertebroplasty procedures. The breakage was attributed to bending of the catheter during retraction and was determined to be a use error. The corrective action is limited to a revision of the Directions for Use.
The affected products were distributed nationwide in the United States, specifically in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI. Users should stop using the affected units and refer to the revised Directions for Use provided by the manufacturer.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Syringe Delivery System, 6", Part Number 2090-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 155
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 (2)
- Manufacturer Part Number 2090-0504
- Lot Numbers A1006026 and A1111020
Distribution
Part of a larger recall action
This product is one of 13 recalled by Orthovita, Inc., dBA Stryker Orthobiologics. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
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