Z-1113-2017Class II

Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set

Name: Z-1113-2017 Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set
Creator: Flower Orthopedics Corporation
Published: 2016-12-22
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2016-12-22 / Terminated / root cause: design

FDA source

Flower Orthopedics Corporation began a recall of Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set on 2016-12-22. FDA classified it as Class II and gives the reason as "The product is being recalled due to incidence and reports of the product breaking during surgery". 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-1113-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-22
Posted: 2017-01-28
Terminated: 2017-11-27
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Product: Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The product is being recalled due to incidence and reports of the product breaking during surgery.
Root cause tag: design
FDA root cause: Device Design
Action: Flower Orthopedics mailed a letter to customers on December 22, 2016 making them aware of the issue. Customers were asked to return the affected product and to report if any adverse effects resulted from its use.
Distribution: Distributed throughout the United States
Product codes and lots: Device Listing: D267957

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1113-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1113-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-08	2017-01-28

Product code LXH

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)