Stryker Orthobiologics Aliquot Reamer Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 7 units of the Aliquot Reamer, 6" (Part Number 2110-0504) 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 recall is classified as FDA Class II, but the hazard is attributed to use error and the correction is limited to a revision of the Directions for Use, fitting the criteria for a moderate severity recall without reported serious injuries.
Plain-English summary
Stryker Orthobiologics is recalling seven units of the Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6" (Part Number 2110-0504, Lot Number E909007R). 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 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 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 stop using the affected product and refer to the revised Directions for Use.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 6", Part Number 2110-0504 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 7
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 2110-0504
- Lot Number E909007R
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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