Stryker Orthobiologics Aliquot Diamond Needle Recall for Catheter Breakage
Stryker Orthobiologics is recalling 19 units of the Aliquot Diamond Needle due to reported catheter breakage during vertebroplasty procedures.
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 use errors and notes the correction is limited to a revision of the Directions for Use, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 19 units of the Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument, specifically the Aliquot Diamond Needle, 4" (Part Number 2110-0506, Lot Number E909005R). The product is used to facilitate the placement of bone cement in weakened or diminished bone.
The recall was initiated after a few 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 correction for this issue 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 prevent catheter breakage during the procedure.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Diamond Needle, 4", Part Number 2110-0506 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 19
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 2110-0506
- Lot Number E909005R
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.
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