AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indi...
FDA Device Recall #Z-2787-2016 — Class II — July 26, 2016
Recall Summary
| Recall Number | Z-2787-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 26, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Howmedica Osteonics Corp. |
| Location | Allendale, NJ |
| Product Type | Devices |
| Quantity | N/A |
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
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.
Distribution Pattern
NationwideDistribution
Lot / 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
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.