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U.S. Department of Health and Human Services

Class 2 Device Recall Depuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD

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 Class 2 Device Recall Depuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORDsee related information
Date Initiated by FirmFebruary 24, 2011
Date PostedMay 19, 2011
Recall Status1 Terminated 3 on February 20, 2013
Recall NumberZ-2208-2011
Recall Event ID 58037
510(K)NumberK073412 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductDePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 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:  3403404 3411147 3415167 3415244 3417101 3418587  
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Dr
Raynham MA 02767
For Additional Information ContactSAME
508-880-8100
Manufacturer Reason
for Recall		Metal debris in the shaft component of the device
FDA Determined
Cause 2		Manufacturing material removal
ActionDePuy 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 Commerce1126 units
DistributionWorldwide 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 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
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