FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Recall number
- Z-1163-2012
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
- Status
- Terminated
- Initiated
- 2012-01-27
- Posted
- 2012-03-06
- Terminated
- 2015-08-05
- Reason
- Lupine BR Anchor w/ Orthocord may be assembled with an incorrect suture configuration and result in a loose repair
- 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
- 1243 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
- Lot, serial or model codes
- Lot Numbers: 3327379 3375490 3392331 3416200 3420847 3424005 3443257 3443258 3443259 3489544 3496405 3498042 3571650
- 510(k) numbers
- ["K040827"]
- PMA numbers
- not on file
- Product code
- MAI
- Firm FEI
- 1221934
- Firm city
- Raynham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28