Stryker Orthobiologics Aliquot Plunger Recalled for Catheter Breakage
Stryker Orthobiologics is recalling 414 Aliquot Plungers because the catheter may break during removal from the needle. The issue is attributed to user error, and the correction involves revised instructions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where injury has not been explicitly reported, but the risk of harm (catheter breakage) is present, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Orthovita, Inc., dBA Stryker Orthobiologics, is recalling 414 units of the Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6" (Part Number 2110-0501). The affected units are identified by Lot Numbers E909004R and E909004. These 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.
The recall is due to reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. The breakage has been attributed to bending of the catheter during retraction from the needle. The manufacturer determined that these incidents were the result of use errors.
The corrective action for this recall is limited to a revision of the Directions for Use. No specific consumer action is explicitly detailed in the source text beyond the manufacturer's revision of the instructions.
The recalled product
- Product
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Plunger, 6", Part Number 2110-0501 Product Usage: Facilitate placement of bone cement in weakened or diminished bone
- Manufacturer
- Orthovita, Inc., dBA Stryker Orthobiologics.
- Hazard
- Affected units
- 414
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 2110-0501
- Lot Numbers E909004R and E909004
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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