| Class 2 Device Recall Stryker stretcher, Model 1015. | |
Date Initiated by Firm | November 15, 2004 |
Date Posted | November 10, 2007 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number | Z-0228-2008 |
Recall Event ID |
37214 |
Product Classification |
Stretcher - Product Code FPO
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Product | Stryker M-Series wheeled stretcher, Model 1015 (SM204), Stryker Medical, Portage, MI 49002 |
Code Information |
All stretchers with serial numbers beginning with 0309 through 0505. |
Recalling Firm/ Manufacturer |
Stryker Medical Div. of Stryker Corporation 3800 E. Centre Ave. Portage MI 49002
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For Additional Information Contact | 800-669-4968 Ext. 6689 |
Manufacturer Reason for Recall | The brake cams may crack or develop excessive wear, resulting in the brakes not locking the wheels, or the stretcher not being locked firmly in position. |
FDA Determined Cause 2 | Component change control |
Action | The firm issued an Urgent Medical Device Correction Letter dated 9/24/07, to each consignee informing them of the problems, that the brakes on each affected stretcher needed to be inspected/tested and removed from service if brake problems were discovered, and that a Stryker service representative would be in contact to replace the brakes. |
Quantity in Commerce | 81,367 (61,708 U.S. and 19,569 ex-U.S.) for all models. |
Distribution | Worldwide-USA, Argentina, Australia, Brazil, Canada, Chile, China, Dubai, France, India, Italy, Japan, Germany, Greece, Hong Kong, Korea, Latin America, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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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