Z-1810-2008

Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet...

Name: Z-1810-2008 Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet...
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2008-04-29
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2008-04-29 / Terminated / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in... on 2008-04-29. The reason FDA records is "Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk...". 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-1810-2008
Status: Terminated
Initiated: 2008-04-29
Posted: 2008-09-17
Terminated: 2008-10-02
Recalling firm: DePuy Mitek, Inc.
Product: Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor, size 2 (5 metric) Braided Composite Suture, violet 36" (91cm) Size 2 (5metric) eyelet loop. Made in Switzerland; Sterile. The Lupine BR Anchor System is indicated for use in soft tissue bone fixation.
Product code: JDR Staple, Fixation, Bone
Reason for recall: Lupine BR Anchor w/Orthocord was assembled with an incorrect suture configuration. The suture loop was not assembled at the distal end of the anchor. It was only threaded through the suture hole in the anchor. Risk associated with incorrect suture configuration include premature breakage.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: DePuy Mitek notified customers by letter dated April 29, 2008 titled Urgent: Voluntary Medical Device Recall Letter asking consignees to isolate and do not use product and to return any of the identified product to DePuy Mitek using enclosed prepaid Federal Express shipping labels and to include a photocopy of the completed Business Reply Form. The firm is asking customers to complete the Business Reply Form with a self addressed, stamped envelope indicating level of inventory of the affected product and to return for immediate delivery of replacement product. If you have any questions contact DePuy Mitek Customer Service directly at 1-800-382-4682.
Quantity in commerce: 105 units
Distribution: Class II Recall - Worldwide Distribution --- USA including states of CA, NY, MA, NV, OH, TX, TN, MD, and countries of France, UK, Canada, Spain.
Product codes and lots: Catalog Number 210711 Lot Number 3069512

Product code JDR

K070925Class IIModification to: Bioknotless Br Anchor / Lupine Br AnchorDepuy Mitek, A Johnson & Johnson Company / cleared 2007-05-02

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)