Z-1314-2015Class II

Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable...

Name: Z-1314-2015 Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable...
Creator: Flower Orthopedics Corporation
Published: 2015-02-16
License: https://open.fda.gov/license/

FLOWER ORTHOPEDICS Corporation dba Conventus Flower / initiated 2015-02-16 / Terminated / root cause: design

FDA source

Flower Orthopedics Corporation began a recall of Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle... on 2015-02-16. FDA classified it as Class II and gives the reason as "Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg". 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-1314-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-16
Posted: 2015-03-24
Terminated: 2015-08-06
Recalling firm: FLOWER ORTHOPEDICS Corporation dba Conventus Flower
Product: Variable Angle Locking Peg, D:1.8mm x L:14.0mm; Variable Angle Locking Peg, D:1.8mm x L:16.0mm, Variable Angle Locking Peg, D:1.8mm x L:18.0mm; Variable Angle Locking Peg, D:1.8mm x L:20.0mm; Variable Angle Locking Peg, D:1.8mm x L:22.0mm, Variable Angle Locking Peg, D:1.8mm x L:24.0mm; Variable Angle Locking Peg, D:1.8mm x L:26.0mm. The locking pegs are intended to be used in conjunction with the Flower Orthopedics Distal Radius Plate for osteosynthesis of the radius bone.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg.
Root cause tag: design
FDA root cause: Device Design
Action: On February 16, 2015, Flower Orthopedics generated and distributed a field memo/advisory notice (FOCMB-15-02) to all distributors with locking peg inventory on February 6, 2015. The field memo provided technique guidance to end users. All 12 consignees with remaining inventory (ie.not reported as used) were contacted directly via phone and all have agreed to ship the locking pegs back to Flower Orthopedics. Flower Orthopedics determined that a generic statement to all customers was not necessary for the following reasons detailed above and summarized again here: product was distributed only through direct channels, the health hazard evaluation has determined there is a very low risk to health, and all consignees have been directly contacted already and product inventory is being returned.
Quantity in commerce: 901
Distribution: Distributed in the states of VA, TX, IL, OK, PA, CA, NY, KY, and FL.
Product codes and lots: All lots of Catalog Numbers: FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1314-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-24

Product code HWC

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)