Z-1170-2012

Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in...

Name: Z-1170-2012 Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in...
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 O-C violet Catalog Number: 222980 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-1170-2012
Status: Terminated
Initiated: 2012-01-27
Posted: 2012-03-06
Terminated: 2015-08-05
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 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: 20476 units
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: 3260754 3260755 3267471 3267856 3279142 3283274 3294346 3308178 3316616 3324437 3335675 3335680 3335912 3345809 3348331 3356158 3356931 3363895 3367218 3372238 3376111 3379721 3392180 3396183 3399549 3402848 3407843 3407853 3411158 3411464 3413924 3414791 3415998 3425969 3430034 3432456 3432784 3438970 3442424 3446284 3447178 3456890 3464329 3466042 3469505 3471047 3477613 3482031 3485711 3496678 3504580 3508148 3508476 3508983 3529766 3534930 3539137 3547740 3551900 3554353 3557169 3557795 3558963 3560269 3560274 3562017 3566058 3568048 3571646

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)