FDAClass IIMarch 2, 2016

AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF recall

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…

Why was AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF recalled?

There were two potential interference conditions identified with the way the tubing set attaches to the inserter.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog number 900301, Lot #01131543, 01261508, 10151404, 10271408, 12161403, 12161404, 09021404, 01261509, 10271407, 01261507, 10071415, 05011403, 06241407, 08071402, 10091305, 03041403, 01271412, 07281401, and 11061303. Catalog number 905103, 01131542, 11241408, 12161405, 12161406, 0211501, 01211502, 11241406, 02031403, 06241408, 07161407, 09101402, 09281401, 10251303, 05301402, 11241407, and 12101305.

Product
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…
Recalling firm
Stryker Spine
Quantity
413 units
Distribution
US Nationwide Distribution
Recall date
March 2, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls