FDA Medical Device Recalls (openFDA)
DePuy Mitek, Inc., a Johnson & Johnson Co.: DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
- Recall number
- Z-0529-2013
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Product
- DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancellous bone during Cruciate Ligament Repair/Reconstruction of the knee.
- Status
- Terminated
- Initiated
- 2012-11-16
- Posted
- 2012-12-17
- Terminated
- 2012-12-21
- Reason
- Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
- Root cause
- Packaging process control
- Action
- DePuy Mitek sent an Urgent Voluntary Product Recall letter dated November 16, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to refer to the attached instructions to report their inventory status and for returning the affected product. Customers with questions should call 1-508-880-8477. For questions regarding this recall call 508-880-8100.
- Quantity
- 20
- Distribution
- Nationwide Distribution including IL and NJ
- Lot, serial or model codes
- Lot Number: 3611687
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTO
- 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