FDA Device recall Z-0852-2016
AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in…
- FDA Device
- Class II
- terminated
- Published 2016-03-02
On 2016-03-02 the FDA classified a Class II recall of AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in… by Stryker Spine, citing there were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0852-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-16 |
| Published | 2016-03-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Spine |
| Distribution | US |
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 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 locations: the "junction block" and the "manifold." The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life.
Reason
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Identifiers
| code_info | Catalog number 900301, Lot #01131543, 01261508, 10151404, 10271408, 12161403, 12161404, 09021404, 01261509, 10271407, 0…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0852-2016%22
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