Z-0316-2012

DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use...

Name: Z-0316-2012 DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2011-10-31
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2011-10-31 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association... on 2011-10-31. The reason FDA records is "Incorrect suture configuration". 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-0316-2012
Status: Terminated
Initiated: 2011-10-31
Posted: 2011-11-30
Terminated: 2015-08-05
Recalling firm: DePuy Mitek, Inc.
Product: DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization.
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Incorrect suture configuration
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, DePuy Mitek Inc., sent an "URGENT VOLUNTARY PRODUCT RECALL"letter dated October 31, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to not use or sell any of the identified problem products included in this recall; complete the enclosed business reply form and fax to: 1-508-828-3750 or email to: [email protected] (note: It is important that we receive this business reply form, even if you have no product remaining in your inventory from the affected lots); isolate all inventory and call 1-877-379-4871 for return goods authorization and replacement product; and return all identified affected product to: (USA)- DePuy Mitek, ATTN: Recall Coordinator, 50 Scotland Boulevard, Bridgewater, MA 02324 or (foreign)-GMED Healthcare EDC Quality Dept Rue de Luxembourg 5, ZI Trazegnies, BE-6180 Courcelles, Belgium. If you have any questions or concerns with regard to this program, please contact your local DePuy Mitek Representative or DePuy Mitek Customer Service directly at 1-877-379-4871.
Quantity in commerce: 291 units
Distribution: Worldwide distribution: USA (nationwide) and countries of: Austria, Australia, Brazil, Canada, Estonia,Switzerland, China, Czechoslovakia, Denmark, Spain, Finland, France, Great Britain Israel, India, Japan, Korea, Mexico, Martinique, Norway, Portugal, Sweden, Singapore, Solvonia, and Slovakia.
Product codes and lots: Lot number 3549732; Product code: 210709

Product code MAI

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)