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U.S. Department of Health and Human Services

Class 2 Device Recall Flower Orthopedics Variable Angle Locking Peg

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  Class 2 Device Recall Flower Orthopedics Variable Angle Locking Peg see related information
Date Initiated by Firm February 16, 2015
Date Posted March 24, 2015
Recall Status1 Terminated 3 on August 06, 2015
Recall Number Z-1314-2015
Recall Event ID 70578
510(K)Number K123562  K131657  
Product Classification Screw, fixation, bone - Product Code HWC
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.
Code Information All lots of Catalog Numbers:  FLP 114, FLP 116, FLP 118, FLP 120, FLP 122, FLP 124, FLP 126 
Recalling Firm/
Manufacturer		 Flower Orthopedics Corporation
100 Witmer Rd Ste 280
Horsham PA 19044-2647
For Additional Information Contact Customer Support
215-394-8903
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = FLOWER ORTHOPEDICS CORPORATION
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