Howmedica Osteonics Corp.: Medical Device Recall in 2016 - (Recall #: Z-2787-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

AccuLIF PL 8-12mm 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 patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Additionally, the AccuLIF PL Cages can be used as in adjunct to fusion in patients diagnosed with degenerative scoliosis. The AccuLIF Pl Cages are always to be used with supplemental internal spinal fixation. Additionally, the AccuLIF PL Cages are to be used 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

Product Classification:

Class II

Date Initiated: July 26, 2016

Date Posted: September 21, 2016

Recall Number: Z-2787-2016

Event ID: 74931

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Catalog #400008 Lot #'s 01141602, 01141607, 01141610, 01141612, 01141617, 02021601, 02021603, 02021605, 02161503. 02161504, 02161506, 02161507, 02161508, 02161509, 02161510, 02161511, 02161512, 02161513, 02161514, 02161515, 03061309, 04161501, 04161502, 04161503, 04161504, 04161505, 04161506, 04161507, 04161508, 05171305, 05181505, 05181506, 05181507, 05181508, 05181509, 05181510, 05181511, 05181512, 05181513, 05181514, 05181515, 06031401, 06031402, 06031403, 06031404, 06201309, 07291404, 07291405, 08191310, 08191311, 08261506, 08261507, 08261508, 10111302, 10111303, 10111304, 10111305, 10291405, 10291406, 11101406, 11101407, 11101408, 11101409, 11101410, 11101411, 11121525, 12151510, 12151515, 12151516, 12151523, 12151526 and 12301315

Distribution Pattern:

NationwideDistribution

Voluntary or Mandated:

Voluntary: Firm initiated