Stryker Orthobiologics Aliquot Catheter Recall for Use Error Revision
Stryker Orthobiologics is recalling 27 Aliquot Catheters to revise instructions after reported 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 hazard is attributed to use errors and the correction is limited to a revision of instructions, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Orthobiologics is recalling 27 units of the Aliquot Delivery System Manual Surgical Instrument, specifically the 8-inch Aliquot Catheter (Part Number 2110-0526). The affected units are identified by Lot Numbers E908004R and E908004. These devices are used to facilitate the placement of bone cement in weakened or diminished bone.
The recall was initiated due to a few 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 result of use errors. 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. Healthcare providers should review the revised Directions for Use to ensure proper handling and retraction of the catheter to prevent breakage.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 27
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 2110-0526
- Lot Numbers E908004R and E908004
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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