Z-2211-2011

DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD

Name: Z-2211-2011 DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2011-02-24
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2011-02-24 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of 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... on 2011-02-24. The reason FDA records is "Metal debris in the shaft component of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2211-2011
Status: Terminated
Initiated: 2011-02-24
Posted: 2011-05-19
Terminated: 2013-02-20
Recalling firm: DePuy Mitek, Inc.
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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Metal debris in the shaft component of the device
Root cause tag: manufacturing process
FDA root cause: 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 [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.
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
Product codes and lots: Lot Numbers: 3450116 3452126 3452666 3453955 3455280 3455577 3456000 3456320 3457346 3459759 3462333 3463328 3463735 3464069 3473282 3474524 3476556 3478827 3478828 3478166 3496079 3495846

Product code MBI

K090124Class IIGryphon P Br Ds Anchor W/orthocord,gryphon P Br Anchor W/orthocord, Model 210813,210814Depuy Mitek, A Johnson & Johnson Company / cleared 2009-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)