Medical product: humerus impaction head; catalog#: 110035647; lot#: unknown.
The manufacturer did not receive x-rays, or other source documents for review.
The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned for investigation.
As no lot number was provided, the device history records could not be reviewed.
A cause for this specific event cannot be ascertained from the information provided.
As soon as supplemental information becomes available an updated report will be submitted.
Zimmer biomet¿s reference number of this file is (b)(4).
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