Stryker Orthobiologics Aliquot Catheter Recall for Use Error
Stryker Orthobiologics is recalling 69 Aliquot Catheters due to reported breakage during vertebroplasty procedures attributed to use errors.
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, and the source text explicitly attributes the hazard to use errors with the correction limited to labeling revisions, fitting the criteria for moderate severity.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 69 units of the Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6" (Part Number 2110-0503). The affected units are identified by Lot Numbers E908003R and E908002. These devices are 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 the 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 of the device.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 6", Part Number 2110-0503 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 69
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 2110-0503
- Lot Numbers E908003R and E908002
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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