Lupine BR Anchor w/Orthocord TCP/PLGA Absorbable Anchor… recallZ-1810-2008 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Apr 29, 2008
Terminated All recalls posted in September 2008
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1810-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 29, 2008
- Posted by the FDA
- Sep 17, 2008
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 105 units
- Product code
- JDR
- FDA submissions
- K070925
- 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 description
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.
Code information (models, lots, serial numbers)
Catalog Number 210711 Lot Number 3069512
Other devices under the same FDA submission
4 devices cleared under K070925 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LUPINE ORTHOCORD 210712Medos International Sàrl · SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE357 reports
- BIOKNOTLESS PANACRYL ETHIBOND 212723Depuy Mitek, LLC · Suture, nonabsorbable, synthetic, polyester1 recall33 reports
- BIOKNOTLESS ORTHOCORD ETHIBOND 212722Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall22 reports
- LUPINE ORTHOCORD 210711Medos International Sàrl · Suture, nonabsorbable, synthetic, polyester52 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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