Reported Aug 19, 2020 · Terminated
Calcaneus Plate, Extensile, Small, Left, Catalog Number CPF 101 - Product Usage: intended to be used for internal…
Flower Orthopedics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Flower Orthopedics Corporation · 100 Witmer Rd Ste 280 · Horsham, PA · 19044-2647
Is this the product you have?
- Calcaneus Plate, Extensile, Small, Left
- Catalog Number CPF 101 - Product Usageintended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus
- Lot codes and dates
Lot Number 1909660028UDI 00840118115643
- Amount recalled
- 25
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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