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U.S. Department of Health and Human Services

Class 2 Device Recall AVS Aria Cage

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  Class 2 Device Recall AVS Aria Cage see related information
Date Initiated by Firm August 13, 2018
Create Date October 10, 2018
Recall Status1 Terminated 3 on May 23, 2019
Recall Number Z-0092-2019
Recall Event ID 80971
510(K)Number K151726  
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product AVS Aria Cage, Catalog Number 48753212

Product Usage:
The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
Code Information Lot Number 7HX
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Tim Huntington
201-760-8000
Manufacturer Reason
for Recall		 The anterior and posterior markers on the cage were on the incorrect/opposite sides of the cage.
FDA Determined
Cause 2		 Error in labeling
Action Product Recall notification letters dated 8/9/18 were distributed to Branch Managers instructing them to: Regional Sales Managers and Agency Principals are ultimately responsible for the following: 1. Examine your inventory and hospital I health care facility locations to identify any AVS ARIA cages with Catalog Number referenced above. 2. If there is any product located at a Health Care Facility I Hospital or end user, the branch/agency must coordinate with a sales representative or Branch/Agency personnel to retrieve the product from the Health Care Facility I Hospital or end user. When retrieving product located at a Health Care Facility I Hospital or end user, the sales representative must do the following: Deliver the Health Care Facility Recall Notification letter to the Health Care Facility I Hospital Representative that the sales representative is retrieving the product from. Have the Health Care Facility I Hospital Representative fill out and sign the Product Recall Acknowledgement Form (attached to Health Care Facility Notification letter). Return the affected products retrieved and the completed Product Recall Acknowledgement Form to the branch/agency personnel responsible for executing the recall. 3. Use Customer Response Form to reconcile any affected product listed above. Complete Customer Response Form even if there is no effected product identified. 4. Within 5 days of receipt of this notice, the branch/agency personnel responsible for executing the recall must send completed and signed the Customer Response Form and the Product Acknowledgement Forms (from the Health Care Facilities) if applicable to Stryker Spine via: email: Spine-RegulatorvActions@Strvker.com All forms must filled out completely and all information must be reconciled accurately 5. Within 5 days of receipt of this notice, mail any affected product via FedEx Acct # 346869500 to: Attn: Christa Joisil - Regulatory Compliance Stryker Spine, 59 Route 17S All
Quantity in Commerce 5
Distribution US Nationwide in the states: CA, FL, GA, MI, MN, NJ, NM, and OR
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 = Stryker Corporation
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