Stryker Spine Recalls AccuLIF Tubing Sets Due to Interference
Stryker Spine is recalling 413 AccuLIF PL and TL Tubing Sets because two potential interference conditions were identified with how the tubing attaches to the inserter.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential mechanical interference hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Stryker Spine is recalling 413 units of the AccuLIF PL Tubing Set (catalog #900301) and AccuLIF TL Tubing Set (catalog #905103). These Class 2 medical devices are used to deliver pressurized saline to the AccuLIF interbody implant for in-situ expansion. The tubing sets attach to the AccuLIF Insertion handle at the junction block and manifold.
The recall was initiated because two potential interference conditions were identified with the way the tubing set attaches to the inserter. The affected units were distributed nationwide in the United States.
Healthcare providers and patients should stop using the affected tubing sets and contact Stryker Spine for further instructions. The specific lot numbers affected are listed in the official recall documentation.
The recalled product
- 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
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 413
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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