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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Spine

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 Class 2 Device Recall Stryker Spinesee related information
Date Initiated by FirmDecember 18, 2015
Create DateFebruary 19, 2016
Recall Status1 Terminated 3 on August 01, 2016
Recall NumberZ-0828-2016
Recall Event ID 73180
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductStryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space.
Code Information Lot #144933, 14D252, and 14D253. 
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information ContactNabil Raz
201-760-8000
Manufacturer Reason
for Recall		Reported jamming of the impaction handle when assembled to the Inserter guide at the threads.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionStryker Spine sent Urgent Product Removal notification letters to branches/agencies on 12/18/2015 via FedEx. The letters provided a description of the affected product, the issue, potential hazards and risk mitigations, and actions to be taken. Customers were asked to examine their inventory and hospital locations to identify the product and reconcile with the affected catalog and lot numbers provided. The Customer Response Form and Product Quantity Tracking Spreadsheet for Health Care Facilities should be completed and returned within five days of receipt of the notice to the e-mail or fax number provided. Questions can be directed to Nabil Riaz - Regulatory Compliance Specialist, Regulatory Compliance & Quality Systems at Nabil.Riaz@Stryker.com.
Quantity in Commerce31 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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.
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