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 CinchLock SS Knotless Anchor with Inserter

  • 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 CinchLock SS Knotless Anchor with Insertersee related information
Date Initiated by FirmApril 12, 2016
Create DateMay 10, 2016
Recall Status1 Terminated 3 on December 12, 2016
Recall NumberZ-1634-2016
Recall Event ID 73846
510(K)NumberK131769 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductCinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT02463) are non-degradable implant devices intended for the fixation of soft tissue to bone. Used for repair of hip, shoulder, foot and ankle, elbow, wrist and hand and knee.
Code Information Model number: CAT02462 Serial numbers: 15120801, 15121401, 16010402, 16011901, 16012501.
FEI Number 2936485
Recalling Firm/
Manufacturer		 Stryker Corporation
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information ContactMichael Hilldoerfer
408-754-2664
Manufacturer Reason
for Recall		Stryker Endoscopy is recalling the CinchLock SS Knotless Anchor with Inserter and the CinchLock Flex Anchor with Inserter after 13 reports of s of an internal wire breaking upon deployment of the anchor.
FDA Determined
Cause 2		Device Design
ActionUrgent Medical Device Recalls letters were sent on April 12, 2016 to US customers by certified mail. Stryker International distribution sites will be notified by e-mail. Letters describe the reason for recall with the affected part and lot numbers. Any recalled product should be segregated and returned to Stryker.
Quantity in Commerce3100 total device, both model numbers.
DistributionDistributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MBI
-
-