Reported Jun 5, 2013 · Terminated
Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8", Part Number 2110-0526…
Orthovita, Inc., dba Stryker Orthobiologics.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthovita, Inc., dBA Stryker Orthobiologics. · 45 Great Valley Pkwy · Malvern, PA · 19355-1302
Is this the product you have?
- Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Catheter, 8"
- Part Number 2110-0526 Product UsageFacilitate placement of bone cement in weakened or diminished bone
- Lot codes and dates
Manufacturer Part Number 2110-0526Lot Numbers E908004R and E908004
- Amount recalled
- 27
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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