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DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD recallZ-2210-2011 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Feb 24, 2011

Terminated All recalls posted in May 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Metal debris in the shaft component of the device

FDA root cause category: Manufacturing material removal

What the company is doing

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 [email protected] 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.

Recall details

Recall number
Z-2210-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 24, 2011
Posted by the FDA
May 19, 2011
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
3894 units
Product code
MBI
FDA submissions
K090124
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

Product description

DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code: 210813 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 (models, lots, serial numbers)

Lot Numbers:  3449990 3451672 3452663 3453946 3455144 3455703 3456883 3462226 3468839 3473244 3476092 3476648 3477802 3478695 3479693 3484277 3486069 3477068 3494964 3495725

Other devices under the same FDA submission

2 devices cleared under K090124 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 58037).

Sources and updates

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