Stryker Orthobiologics Aliquot Beveled Needle Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 35 units of the Aliquot Beveled Needle because the catheter may break during removal. The issue is attributed to user error, and the correction involves updating the Directions for Use.
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 text explicitly attributes the hazard to user error and notes the correction is limited to documentation, fitting the criteria for a moderate, precautionary recall without reported injuries.
Plain-English summary
Stryker Orthobiologics is recalling 35 units of the Aliquot Delivery System Manual Surgical Instrument, specifically the Aliquot Beveled Needle, 4" (Part Number 2110-0505). The affected units are identified by Lot Numbers E909002 and E909002R. These instruments are used to facilitate the placement of bone cement in weakened or diminished bone during vertebroplasty procedures.
The recall was initiated due to reported cases of the catheter breaking when removing the Aliquot catheter from the needle. The manufacturer attributed this issue to bending of the catheter during retraction, determining it to be a result of use errors. The corrective action is limited to a revision of the Directions for Use to prevent this occurrence.
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. Healthcare facilities and users should check their inventory for the specific part and lot numbers listed and refer to the updated Directions for Use.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 35
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 2110-0505
- Lot Numbers E909002 and E909002R
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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