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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker AutoPlex System

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  Class 2 Device Recall Stryker AutoPlex System see related information
Date Initiated by Firm November 09, 2017
Create Date March 28, 2018
Recall Status1 Terminated 3 on April 16, 2019
Recall Number Z-1250-2018
Recall Event ID 79418
510(K)Number K032945  
Product Classification Bone cement - Product Code LOD
Product 1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259
Bone cement.
Code Information 1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022   UDI: (01)4546540593108; (01)7613252039259         
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Erin Bissonnette
269-389-5330
Manufacturer Reason
for Recall		 Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
FDA Determined
Cause 2		 Environmental control
Action Letters dated November 16, 2017, were sent to customers. Actions to be taken by the Customer/User: 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine if any devices from the affected lots are at your facility. 3. Quarantine and discontinue use of the recalled devices. 4. Complete and sign the enclosed Business Reply Form (BRF). 5. If you have further distributed these products, please forward this letter and the attached BRF to all affected locations. Please indicate each location on the BRF. 6. Return the completed BRF to Stryker Instruments Post Market Regulatory Compliance via fax (866-521- 2762) or email (erin.bissonnette@stryker.com). 7. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. 8. Report any adverse events associated with the use of these devices to Stryker Instruments 1-800-253-3210, including any infections potentially associated with the use of affected product.
Quantity in Commerce 1244
Distribution Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
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 = LOD and Original Applicant = STRYKER CORP.
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