The Recall Desk
HighFDA (Devices)·Z-2786-2016·Announced 2016-09-21

Howmedica Recalls AccuLIF PL Spinal Cages Due to Height Reduction

Howmedica Osteonics Corp. is recalling AccuLIF PL spinal cages because some implants have shown a reduction in height greater than 1 mm after surgery.

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 structural defect (height reduction) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cages. These medical devices are indicated for intervertebral body fusion in patients with degenerative disc disease or degenerative scoliosis. The recall covers specific catalog and lot numbers distributed nationwide.

The recall is being conducted because product inquiries have confirmed that some AccuLIF PL implants have experienced a reduction in height greater than 1 mm following surgery. Since Stryker acquired the product in March 2014, the occurrence rate for this issue is approximately 0.47%, with a slight upward trend noted since September 2015.

Patients who have received these specific implants should contact their healthcare provider to discuss the findings and determine if any follow-up care is necessary.

The recalled product

Product
AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for intervertebral body fusion with autograft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjun
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Spinal Implant
Hazard

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 #400006 Lot #'s 01141604
  • 01141609
  • 01141614
  • 01231506
  • 01231507
  • 01271513
  • 01271514
  • 02021508
  • 02021509
  • 02021510
  • 02021511
  • 03271306
  • 04291403
  • 04291404
  • 04301513
  • 04301514
  • 04301515
  • 04301516
  • 06251504
  • 06291506

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · structural defect

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