Class 2 Device Recall Stryker AccuLIF PL Cages

• Date Initiated by Firm: July 26, 2016
• Create Date: September 12, 2016
• Recall Status: Terminated on March 12, 2018
• Recall Number: Z-2786-2016
• Recall Event ID: 74931
• 510(K)Number: K132505 K143616 K141217
• Product Classification: Intervertebral fusion device with bone graft, lumbar - Product Code MAX
• 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.
• Code Information: 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
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 2 Pearl Ct; Allendale NJ 07401-1611
• For Additional Information Contact: Mr. Tim Huntington; 201-749-8346
• Manufacturer 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.
• FDA Determined 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.
• Distribution: NationwideDistribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MAX and Original Applicant = COALIGN INNOVATIONS, INC.; 510(K)s with Product Code = MAX and Original Applicant = STRYKER CORPORATION