Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage Risk
Stryker Orthobiologics is recalling five Aliquot Reamer units because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.
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 recall is classified as FDA Class II, but the source explicitly attributes the hazard to use errors and notes the correction is limited to documentation revision, fitting the criteria for moderate severity involving low-risk issues or voluntary precautionary measures.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling five units of the Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525. The product is used to facilitate the placement of bone cement in weakened or diminished bone. The recall is limited to Lot Number E909006R.
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 result of use errors. The corrective action is limited to a revision of the Directions for Use.
The affected units 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 refer to the revised Directions for Use to ensure proper handling of the device.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 5
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 2110-0525
- Lot Numbers E909006R
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