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Depuy Mitek Lupine Loop DS w/Orthocord recallZ-1171-2012 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Jan 27, 2012

Terminated All recalls posted in March 2012

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

Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair

FDA root cause category: Process control

What the company is doing

DePuy Mitek sent an Urgent Voluntary Product Recall letter dated January 27, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to immediately check all inventories to determine if they have any affected product. Customers were asked to refer to the instructions to report their inventory status, return and obtain replacement or credit for the product. For questions regarding this recall call 1-877-379-4871.

Recall details

Recall number
Z-1171-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 27, 2012
Posted by the FDA
Mar 6, 2012
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
12774
Product code
MAI
FDA submissions
K040827
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Canada, AE, Argentina, Australia, Austria,Belgium,Brazil, Bahrain, Chile, China, Columbia,Cyprus, Check Republic, Germany, Denmark, Ecuador, Egypt, Spain, Finland, France, Finland, Great Britain, Guadeloupe, Hong Kong, Hungary,Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Luxembourg,Latvia, Martinique, Montenegro, Mexico, Maylasia, Netherlands,Norway, New Zealand, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Tunisia, Turkey,Uruguay, Venezuela, and South Africa

Product description

Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

Code information (models, lots, serial numbers)

Lot Numbers: 3262755 3262756 3270106 3291257 3307440 3323863 3335678 3343572 3354334 3363896 3372273 3375075 3380458 3394953 3408382 3408383 3416204 3423417 3425970 3431092 3432783 3441035 3447934 3455145 3459761 3464330 3492974 3504852 3508403 3508489 3525498 3528634 3534545 3540175 3541390 3550945 3554352 3556295 3557173 3558967 3562227 3566060 3568042 3568050

Other devices under the same FDA submission

6 devices cleared under K040827 — 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 61088).

Sources and updates

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