Reported Mar 2, 2016 · Terminated
AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to…
Stryker Spine
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: Stryker Spine · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for in-situ expansion. The Tubing Set attaches to the AccuLIF Insertion
- handle at two district locationsthe "junction block" and the "manifold." The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life
- Lot codes and dates
Catalog number 900301Lot #011315430126150810151404102714081216140312161404090214040126150910271407012615071007141505011403062414070807140210091305030414030127141207281401and 11061303. Catalog number 90510301131542112414081216140512161406021150101211502112414060203140306241408071614070910140209281401102513030530140211241407and 12101305
- Amount recalled
- 413 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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