FDA Medical Device Recalls (openFDA)
In2Bones, SAS: In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
- Recall number
- Z-1283-2021
- Recalling firm
- In2Bones, SAS
- Product
- In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
- Status
- Terminated
- Initiated
- 2021-02-09
- Posted
- not on file
- Terminated
- 2024-07-11
- Reason
- This Field Action is being conducted following identification of manufacturing non-conformity of some batches of Shannon burrs diameter 2.0mm length 20mm, possibly causing the breakage of the burr during use.
- Root cause
- Device Design
- Action
- A "FIELD CORRECTIVE ACTION MEDICAL DEVICE BATCH RECALL" and reply form dated 02/09/2021 were sent to customers.
- Quantity
- 60 units
- Distribution
- US Nationwide distribution in the state of TN.
- Lot, serial or model codes
- Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFF
- Firm FEI
- 3010470577
- Firm city
- Ecully
- Firm state
- not on file
- Firm country
- France
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