AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an… — Class II medical device recall Z-0852-2016
Terminated recall by Stryker Spine, reported 2016-03-02, distributed nationwide. There were two potential interference conditions identified with the way the tubing set attaches to the insert
| Recall number | Z-0852-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2015-12-16 |
| Classified | 2016-02-23 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-08-01 |
| Distributed | Nationwide (US) |
| Quantity | 413 units |
| Lot numbers | 01131543, 01261507, 01261508, 01261509, 01271412, 03041403, 05011403, 06241407, 07281401, 08071402, 09021404, 10071415, 10091305, 10151404, 10271407, 10271408, 11061303, 12161403, 12161404 |
| Model numbers | 01131542, 01211502, 02031403, 0211501, 05301402, 06241408, 07161407, 09101402, 09281401, 10251303, 11241406, 11241407, 11241408, 12101305, 12161405, 12161406, 900301, 905103 |
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 for recall
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0852-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.