Z-1164-2012

Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated...

Name: Z-1164-2012 Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated...
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 Plus Anchor w/ Panacryl Catalog Number: 210707 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-1164-2012
Status: Terminated
Initiated: 2012-01-27
Posted: 2012-03-06
Terminated: 2015-08-05
Recalling firm: DePuy Mitek, Inc.
Product: Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 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: 1757 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: 3382594 3404938 3443265 3474050 3513370 3551904

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)