Date Initiated by Firm |
April 12, 2016 |
Create Date |
May 10, 2016 |
Recall Status1 |
Terminated 3 on December 12, 2016 |
Recall Number |
Z-1634-2016 |
Recall Event ID |
73846 |
510(K)Number |
K131769
|
Product Classification |
Fastener, fixation, nondegradable, soft tissue - Product Code MBI
|
Product |
CinchLock 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. |
Recalling Firm/ Manufacturer |
Stryker Corporation 5900 Optical Ct San Jose CA 95138-1400
|
For Additional Information Contact |
Michael 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 |
Action |
Urgent 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 Commerce |
3100 total device, both model numbers. |
Distribution |
Distributed US (nationwide) and in Australia, Switzerland, Netherlands, Spain and Sweden. |
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.
|
510(K) Database |
510(K)s with Product Code = MBI and Original Applicant = PIVOT MEDICAL INC.
|