Howmedica Osteonics Corp.: 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.

Agency Publication Date: September 12, 2016

Affected Products

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 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 r

Catalog #400006 Lot #'s 01141604, 01141609, 01141614, 01231506, 01231507, 01271513, 01271514, 02021508, 02021509, 02021510, 02021511, 03271306, 04291403, 04291404, 04301513, 04301514, 04301515, 04301516, 06251504, 06291506, 06291507, 06291508, 06291509, 06291510, 06291511, 07081301, 07201503, 07201504, 07201505, 07201506, 08191309, 08251402, 08251403, 09231504, 09251502, 09281510, 10071307, 10071308, 10141504, 10141505, 10261507, 10261508, 11061405, 11061406, 11061407, 11061408, 11121513, 11121517, 11121520, 11121524, 12151512, 12151518, 12151522 and 12301314

Product: 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

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

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 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

Catalog #400010 Lot #'s 01021403, 01121508, 01121509, 01271515, 01271516, 02021512, 02021513, 02021514, 02021515, 02021602, 03221310, 04141508, 04141509, 04141510, 04141511, 04141512, 04251312, 06101405, 06101406, 06101407, 06251311, 07011406, 07201510, 07201511, 07201512, 08141303, 08141313, 09251504, 09281512, 10081301, 10081302, 10201502, 10201503, 10301504, 11121514, 11121518, 11121521, 12151511 and 12151517

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 74931

Status: Resolved

Manufacturer: Howmedica Osteonics Corp.

Manufactured In: United States

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Sources: FDA iRES · Raw API Response

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Affected Products