Recall Z-1314-2015— Flower Orthopedics Corporation

Name: FDA recall Z-1314-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-16

Class II · Terminated

Class II FDA medical device recall by Flower Orthopedics Corporation, initiated 2015-02-16, terminated 2015-08-06. It names 2 FDA 510(k) clearances: K131657, K123562. 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.. Reason: Locking pegs were not locking during distal radius procedures. There has been one (1) report of revision surgery scheduled to remove a loosened peg..

Recalling firm: Flower Orthopedics Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-02-16
Terminated: 2015-08-06
Firm location: Horsham, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K131657 — FLOWER SMALL AND MEDIUM IMPLANT SETFlower Orthopedics Corporation·cleared 2013-08-22
K123562 — FLOWER SMALL AND MEDIUM BONE IMPLANTSFlower Orthopedics Corporation·cleared 2013-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.