Z-1283-2021Class II

In2Bones Shannon Percutaneous Burr -

Name: Z-1283-2021 In2Bones Shannon Percutaneous Burr -
Creator: In2Bones, SAS
Published: 2021-02-09
License: https://open.fda.gov/license/

In2Bones SAS / initiated 2021-02-09 / Terminated / root cause: design

FDA source

In2Bones, SAS began a recall of In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery on 2021-02-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1283-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-09
Posted: 2021-03-19
Terminated: 2024-07-11
Recalling firm: In2Bones SAS
Product: In2Bones Shannon Percutaneous Burr - Product Usage: indicated for forefoot mini-invasive and percutaneous surgery.
Product code: GFF Bur, Surgical, General & Plastic Surgery
Reason for recall: 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 tag: design
FDA 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 in commerce: 60 units
Distribution: US Nationwide distribution in the state of TN.
Product codes and lots: Model G01 01511, Batches 2009139 and 2001089 Model G01 01512, Batches 2007087 and 2011062

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1283-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1283-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-19

Product code GFF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)