Agency classClass IIOur severity:High FDA (Devices)·Z-2788-2016·Announced 2016-09-21

Howmedica Recalls AccuLIF PL Cages Due to Height Reduction

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

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Howmedica Osteonics Corp. is recalling AccuLIF PL 10-16mm 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 Inquires (PIs) have confirmed a reduction of height greater than 1 mm in the PL implant. Since Stryker acquired the AccuLIF product in March 2014, the occurrence rate for reported post-operative reduction of cage height has been approximately 0.47%, with a slight upward trend noted since September 2015.

Healthcare providers and patients should contact Howmedica Osteonics Corp. for further information regarding the recall and potential replacement or repair options. The source text does not specify specific consumer actions beyond the general recall notification.

The recalled product

Product: AccuLIF PL 10-16mm 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…
Manufacturer: Howmedica Osteonics Corp.
Category: Medical Device — Spinal Implant
Hazard: structural-defect
implant-failure

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 #400010 Lot #'s 01021403
01121508
01121509
01271515
01271516
02021512
02021513
02021514
02021515
02021602
03221310
04141508
04141509
04141510
04141511
04141512
04251312
06101405
06101406
06101407

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 →

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · structural defect