FDAJuly 26, 2016device

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 adjunct to fusion in p...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a reduction of height > 1 mm. The current occurrence rate for reported post-operative reduction of cage height (> 1mm) of AccuLIF PL Expandable Cages is approximately 0.47% and has demonstrated a slight upward trend since September 2015.

What to do

FDA enforcement status: Terminated

Brands named

howmedica osteonicshowmedica

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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