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U.S. Department of Health and Human Services

Class 2 Device Recall 6376 M1 Cot Fastener

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  Class 2 Device Recall 6376 M1 Cot Fastener see related information
Date Initiated by Firm March 09, 2018
Create Date May 02, 2018
Recall Status1 Terminated 3 on April 09, 2019
Recall Number Z-1598-2018
Recall Event ID 79817
Product Classification Stretcher, wheeled - Product Code FPO
Product 6376 M-1 Cot Fastener, catalog no. 6376000000
Code Information Serial No. 170740300  170740301  170740302  170740303  170740304  170740305  170740306  170740307  170740308  170740309  170740310  170740311  170740312  170740313  170740314  170740315  170740316  170740317  170740318  170740319  170740320  170740321  170740322  170740323  170740324  170740325  170740326  170740327  170740328  170740329  170740330  170740331  170740332  170740333  170740334  170740335  170740336  170740337  170740338  170740339  170740340  170740341  170740342  170740343  170740344  170740345  170740346  170740347  170740348  170740349  170740350  170740351  170740352  170740353  170740354  170740355  170740356  170740357  170740358  
Recalling Firm/
Manufacturer		 Stryker Medical Division of Stryker Corporation
3800 E Centre Ave
Portage MI 49002-5826
For Additional Information Contact Victoria Haney
269-389-8306
Manufacturer Reason
for Recall		 The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
FDA Determined
Cause 2		 Labeling Change Control
Action On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to productfieldaction@stryker.com 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.
Quantity in Commerce 59
Distribution Product distributed to the Netherlands
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.
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