FDAJuly 8, 2020device
Calcaneus Plate, Extensile, Large, Left, Catalog Number CPF 103 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
What to do
FDA enforcement status: Terminated
Brands named
flower orthopedicsflower
UPCs
00840118115667
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABrand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28 mm Head; 3205.45.028 Klassi...2025-09-23
- FDAReef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System2025-08-06
- FDAtemper tamer, 1 US fl oz. (29.6 mL), Homeopathic Oral Spray, Manufactured by: Siddha Flower Essences, Oxnard, CA, 93030 NDC 69779-020-01.2025-04-28
- FDABeijing Soybean Paste, packaged in 8.82 ounce/250g red and white packages; Ingredients Soybean, Flour, Salt, Water, Potassium Sorbate; UPC: 69177990003852025-04-17
- FDAComprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 1136272025-03-03
- FDABrand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No2024-10-29
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