Terminated

Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

FDA Recall Z-1162-2012 · Posted 2012-03-06

Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.

Recall StatusTerminated

Product CodeMAI

Date Initiated2012-01-27

Date Terminated2015-08-05

Product Quantity41581

Reason for Recall

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

Firm Action

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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040827PANALOK LOOP ANCHORDepuy Mitek, A Johnson & Johnson Company · 2004-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.