Howmedica Osteonics Corp.: 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 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.

Recall number

Z-2786-2016

Recalling firm

Howmedica Osteonics Corp.

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 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.

Status

Terminated

Initiated

2016-07-26

Posted

not on file

Terminated

2018-03-12

Reason

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.

Root cause

Unknown/Undetermined by firm

Action

Stryker Spine sent an "Urgent Recall Letter and Product Accountability Form" dated July 26, 2016 to all affected customers. For patients who have had an AccuLIF Posterior Lumbar (PL) Expandable Interbody implant, Stryker Spine is recommending routine clinical and radiographic post-operated evaluation. Should the patient report any change in or develop near-onset symptoms, more urgent clinical and radiographic evaluation should be completed. Customers with questions should call 201-749-8389 or 201-749-8346.

Quantity

not on file

Distribution

NationwideDistribution

Lot, serial or model codes

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

510(k) numbers

["K132505","K141217","K143616"]

PMA numbers

not on file

Product code

MAX

Firm FEI

3004024955

Firm city

Allendale

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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