Stryker Orthobiologics Aliquot Plunger Delivery System Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 411 units of the Aliquot Plunger Delivery System because the catheter may break during vertebroplasty procedures.
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, but the source text explicitly attributes the issue to use errors and limits the correction to a revision of the Directions for Use, indicating a low-risk, voluntary precautionary recall without reported injuries.
Plain-English summary
Stryker Orthobiologics is recalling 411 units of the Aliquot Plunger Delivery System, 4", Part Number 2090-0501. The product is a manual surgical instrument used to facilitate the placement of bone cement in weakened or diminished bone. The recall affects Lot Numbers A1109035 and Q1006002, which were distributed nationwide in the United States.
The recall was initiated due to reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. The breakage was attributed to bending of the catheter during retraction from the needle and was determined to be a use error. The corrective action is limited to a revision of the Directions for Use.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger Delivery System, 4", Part Number 2090-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 411
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 2090-0501
- Lot Numbers A1109035 and Q1006002
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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