Z-0852-2016Class II

AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic...

Name: Z-0852-2016 AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic...
Creator: Stryker Spine
Published: 2015-12-16
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2015-12-16 / Terminated / root cause: design

FDA source

Stryker Spine began a 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-situ. The purpose... on 2015-12-16. FDA classified it as Class II and gives the reason as "There were two potential interference conditions identified with the way the tubing set attaches to the inserter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0852-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-16
Posted: 2016-02-23
Terminated: 2016-08-01
Recalling firm: Howmedica Osteonics Corp
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.
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Reason for recall: There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Root cause tag: design
FDA root cause: Device Design
Action: Stryker Spine sent an Urgent Product Removal letter dated December 17, 2015 to affected customers via Fed Ex priority overnight. The letter identified the affected product, problem and actions to be taken. Customers are asked to follow instructions included in the letter. The customer response form should be completed and sent back to email via [email protected] or Fax 855-632-9049. For questions call (201)749-8389.
Quantity in commerce: 413 units
Distribution: US Nationwide Distribution
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0852-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0852-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-02	2016-02-23

Product code MAX

K143616Class IIAccuLIF TL and PL CageStryker Corporation / cleared 2015-03-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)