The Recall Desk
SevereFDA (Devices)·Z-1616-2016·Announced 2016-05-18

Atlas Spine Torque Limiting Handle Recalled for Implant Fracture Risk

Atlas Spine, Inc. is recalling 16 Torque Limiting Handles because they were not appropriately set to mitigate the risk of implant fracture during rotation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of implant fracture, which constitutes a significant injury risk under the severity rubric.

Plain-English summary

Atlas Spine, Inc. is recalling 16 units of the Atlas Spine Torque Limiting Handle 6N-m (P/N 70089, Model # ITN-001-000). The device is used to rotate implants into position. The recall covers lots 8887, 000073, 000135, 00434, and 02518.

The recall was initiated because the device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space. The FDA has classified this as a Class II recall.

The affected units were distributed nationwide to Florida, Missouri, and West Virginia. No specific instructions for consumers are provided in the source text, but the recall is managed by Atlas Spine, Inc.

The recalled product

Product
Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position
Manufacturer
Atlas Spine, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
16

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 (5)

  • Lots #: 8887
  • 000073
  • 000135
  • 00434
  • and 02518.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

Same manufacturer · Atlas Spine, Inc.

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Same hazard · implant fracture

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