CLASS II Device recall · Reported 21 Sep 2016 · FDA Enforcement Report
AccuLIF PL 8- x 8 Cage recalled by Howmedica Osteonics
Howmedica Osteonics is recalling AccuLIF PL 8- x 8 Cage, distributed nationwide in the US. The recall was initiated on 26 Jul 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2787-2016
- FDA event ID
- 74931
- Recalling firm
- Howmedica Osteonics, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2016
- FDA classified
- 12 Sep 2016
- Reported
- 21 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Spinal Implants
Timeline
| 26 Jul 2016 | Recall initiated by company | |
| 12 Sep 2016 | Classified by FDA | +48 days |
| 21 Sep 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
NationwideDistribution
Questions about this recall
Is AccuLIF PL 8- x 8 Cage recalled?
Yes. Howmedica Osteonics recalled AccuLIF PL 8- x 8 Cage on 26 Jul 2016. The recall is Class II and its status is Terminated. Recall number Z-2787-2016.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
NationwideDistribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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