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DePuy Mitek Lupine Loop Plus w/ Orthocord recallZ-0315-2012 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Oct 31, 2011

Terminated All recalls posted in November 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

Incorrect suture configuration

FDA root cause category: Employee error

What the company is doing

The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: [email protected] (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.

Recall details

Recall number
Z-0315-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 31, 2011
Posted by the FDA
Nov 30, 2011
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
299 units
Product code
MAI
FDA submissions
K062170, K070925
Distribution
Worldwide distribution: USA (nationwide) and countries of: Austria, Australia, Brazil, Canada, Estonia,Switzerland, China, Czechoslovakia, Denmark, Spain, Finland, France, Great Britain Israel, India, Japan, Korea, Mexico, Martinique, Norway, Portugal, Sweden, Singapore, Solvonia, and Slovakia.

Product description

DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.

Code information (models, lots, serial numbers)

Lot number 3549296; Product code: 210708

Other devices under the same FDA submission

10 devices cleared under K062170, K070925 — 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 60287).

Sources and updates

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