Recall Z-0852-2016
Stryker Spine · initiated December 16, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
Reason for recall
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
FDA-determined cause: Device Design
Action taken
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 Spine-RegulatoryActions@Stryker.com or Fax 855-632-9049. For questions call (201)749-8389.
Details
- Recall number
- Z-0852-2016
- Initiated
- December 16, 2015
- Terminated
- August 1, 2016
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Quantity
- 413 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Stryker Spine, Allendale, NJ