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.
What this means for you
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
Same manufacturer · Orthovita, Inc., dBA Stryker Orthobiologics.
See all →- HighStryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects
FDA (Devices) · 2015-09-23
- ModerateStryker Recalls Vitagel Surgical Hemostat Due to Cold Chain Violations
FDA (Devices) · 2015-04-08
- ModerateStryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Recall
FDA (Devices) · 2015-01-14
- ModerateStryker Orthobiologics Recalls Imbibe Bone Marrow Aspiration Needles
FDA (Devices) · 2015-01-14
- ModerateStryker Orthobiologics Aliquot Diamond Needle Recall for Catheter Breakage
FDA (Devices) · 2013-06-05
Same hazard · device breakage
See all →- HighPeripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighTissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighTissium Peripheral Nerve Repair Device Shelf Life Recall
FDA (Devices) · 2026-08-12
- HighSurgify Halo Surgical Burr Breakage Risk During Spinal Surgery
FDA (Devices) · 2026-07-01
- SevereSurgify Halo 4.0mm Extendable Surgical Burr Recall for Breakage Risk
FDA (Devices) · 2026-07-01