Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Stryker stretcher, Model 722.

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Stryker stretcher, Model 722. see related information
Date Initiated by Firm November 15, 2004
Date Posted November 10, 2007
Recall Status1 Terminated 3 on October 27, 2010
Recall Number Z-0222-2008
Recall Event ID 37214
Product Classification Stretcher - Product Code FPO
Product Stryker OEM wheeled stretcher, Model 722, 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
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
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.
-
-