Recall record at a glance
| Official record | Z-0603-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Miami Device Solutions, LLC. |
| Report date | Dec 11, 2019 |
| Recall initiation date | Jan 15, 2019 |
| Quantity | 15 units |
| Location | Miami, FL, United States |
Official product description
Proximal Humerus Plate, 8 holes, Right, REF MDS130108R - Product Usage: The Proximal Humerus Plating System consists of plates, screws, and locking caps intended to provide internal fixation of fractures of the proximal humerus. The polyaxial screws have a range of motion of +/- 20. The screws can be simply lagged or locked to the plate with the addition of a locking cap. The plates are side specific implants.
Why the product was recalled
Right Proximal Humerus Plates. Product component parts MDS130108R, may be improperly identified as left.
Distribution information
US Nationwide distribution in the states of FL, RI, MA, PA, NY, OH, GA, WA, AL, CA, TX, VA.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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