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 MMP 200

  • 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 MMP 200see related information
Date Initiated by FirmJanuary 28, 2011
Date PostedMarch 08, 2011
Recall Status1 Terminated 3 on March 30, 2011
Recall NumberZ-1611-2011
Recall Event ID 58045
ProductMMP 200 Articulating Booms, Catalog Number 0682-000-604SX, Product Number 0682-001-060C. Used for operating room equipment.
Code Information Serial numbers 02074510100008 and 0207451010000
Recalling Firm/
Manufacturer		 Stryker Communications Corp
1410 Lakeside Pkwy Ste 100
Flower Mound TX 75028-4026
For Additional Information Contact
972-410-7310
Manufacturer Reason
for Recall		Utilization of incorrect screws resulted in inadequate thread engagement reducing the load bearing capability of the product.
FDA Determined
Cause 2		Process control
ActionStryker notified consignees verbally on January 28, 2011 and by letter dated February 11, 2011.
Quantity in Commerce2
DistributionMA, CO
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.
-
-