FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
- Recall number
- Z-0145-2013
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
- Status
- Terminated
- Initiated
- 2012-09-06
- Posted
- 2012-10-25
- Terminated
- 2015-06-03
- Reason
- Fracture of SPIRALOK Anchors post op, requiring patient revision
- Root cause
- Device Design
- Action
- DePuy Mitek sent an Urgent Voluntary Product Recall letter dated September 6, 2012, to all affected customers. Dr Doctor letters were included with the recall letter. Recall is coordinated with Stericycle , contact 1-888-202-3694 The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the enclosed Business Reply Form, even if they have no product remaining in their inventory. Customers were instructed to isolate all inventory of the affected product and return to Stericycle at the following address or fax to 1-888-912-2189 with the completed Business Reply Form: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event #8874 Customers with questions were instructed to call 1-888-202-3694. For questions regarding this recall call 508-880-8100.
- Quantity
- 232 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of AE, AR, AT, AU, BE, BR, CA,, CH,CL .CN, CO, CZ,DE, DK, EC, ES, FI, FR GB, GP, GR, IE, IL, IN, IT, KR, LU, LY, MX, NC NL, NO, NZ, PE, PL PT, RE, RU, SG, SI, TH, TN, TR, UG ,UY , VE, and ZA.
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- ["K041069","K060271"]
- PMA numbers
- not on file
- Product code
- HWC
- 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