Z-1171-2012

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

Name: Z-1171-2012 Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2012-01-27
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2012-01-27 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation on 2012-01-27. The reason FDA records is "Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair". 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-1171-2012
Status: Terminated
Initiated: 2012-01-27
Posted: 2012-03-06
Terminated: 2015-08-05
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 12774
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 codes and lots: 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

Product code MAI

K040827Class IIPanalok Loop AnchorDepuy Mitek, A Johnson & Johnson Company / cleared 2004-04-30

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)