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 DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD

  • 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 DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD see related information
Date Initiated by Firm February 24, 2011
Date Posted May 19, 2011
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-2211-2011
Recall Event ID 58037
510(K)Number K090124  
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
Product DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD
Product Code: 210814
Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, UInar or Radial Collateral Ligament Reconstruction.
Code Information Lot Numbers:  3450116 3452126 3452666 3453955 3455280 3455577 3456000 3456320 3457346 3459759 3462333 3463328 3463735 3464069 3473282 3474524 3476556 3478827 3478828 3478166 3496079 3495846 
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information Contact SAME
508-880-8100
Manufacturer Reason
for Recall		 Metal debris in the shaft component of the device
FDA Determined
Cause 2		 Manufacturing material removal
Action DePuy Mitek sent an Urgent Voluntary Product Recall Notification letter dated February 24, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check their inventory to determine if they have any affected product. Customers were asked to complete the enclosed business reply form and fax it to 508-828-3750 or email to mitekcomplaints@its.jnj.com whether or not they have any of the affected product remaining in their inventory. Customers were asked to utilize the return good authorization number provided by customer service and return all identified product to: DePuy Mitek ATTN: Recall Coordinator 50 Scotland Boulevard Bridgewater, MA 02324 For any questions call 1-877-379-4871 or contact DePuy Mitek Customer Service directly at 1-800-382-4682, PROMPT 3.
Quantity in Commerce 4141 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Austrailia Austria Belgium Canada China Estonia Finland France Germany Great Britain Indonesia Ireland Italy Japan Lebanon Lithuania Netherlands Poland Singapore Slovenia South Africa Spain Sweden and Switzerland
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.
510(K) Database 510(K)s with Product Code = MBI and Original Applicant = DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
-
-