Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond recallZ-1162-2012 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Jan 27, 2012
Terminated All recalls posted in March 2012
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 may be assembled with an incorrect suture configuration and result in a loose repair
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1162-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 27, 2012
- Posted by the FDA
- Mar 6, 2012
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 41581
- Product code
- MAI
- FDA submissions
- K040827
- 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 description
Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
Lot Numbers: 3254455 3254464 3254772 3262313 3270104 3276492 3278110 3278111 3286624 3286916 3286917 3286918 3287309 3287311 3287390 3287392 3295568 3295569 3297682 3297683 3299220 3304047 3304048 3304049 3305321 3305430 3305681 3305682 3305683 3306004 3306391 3306677 3307006 3334454 3334455 3334634 3334635 3345378 3345379 3370177 3370178 3370180 3370783 3371236 3371239 3371241 3371615 3377559 3377561 3377562 3383125 3383127 3383265 3383266 3383267 3383268 3383623 3384221 3384222 3396398 3396503 3396504 3397755 3412266 3412270 3412856 3414484 3414533 3415555 3415714 3416128 3417104 3418602 3420846 3423623 3424661 3425288 3426996 3427237 3427238 3428991 3432156 3433007 3437113 3442445 3443870 3447918 3450122 3451457 3456002 3456269 3456435 3459762 3464533 3466040 3468840 3471144 3473778 3476081 3477621 3478976 3484026 3486327 3489054 3489725 3491267 3494653 3494656 3494917 3501542 3502156 3502967 3503801 3504239 3507680 3508146 3508905 3509441 3509538 3509541 3509956 3510410 3511003 3518413 3523828 3527730 3528739 3531511 3533828 3540939 3541612 3542349 3549274 3551177 3556763 3556770 3560268 3564054 3570366 3570374 3571653
Other devices under the same FDA submission
6 devices cleared under K040827 — 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
- LUPINE ORTHOCORD 222980Depuy Mitek, LLC · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID11 reports
- LUPINE 210704Depuy Mitek, LLC · Fastener, fixation, biodegradable, soft tissue3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 61088).
- Z-1163-2012 · TerminatedDepuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1164-2012 · TerminatedDepuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1165-2012 · TerminatedDepuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1166-2012 · TerminatedDepuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1167-2012 · TerminatedDepuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1168-2012 · TerminatedDepuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1169-2012 · TerminatedDepuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1170-2012 · TerminatedDepuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Z-1171-2012 · TerminatedDepuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
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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