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Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl recallZ-1163-2012 · 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-1163-2012
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
1243 units
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 (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

Code information (models, lots, serial numbers)

Lot Numbers: 3327379 3375490 3392331 3416200 3420847 3424005 3443257 3443258 3443259 3489544 3496405 3498042 3571650

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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