Medtronic Sofamor Danek USA Inc recalls Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
- Recall date
- April 13, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2047-2017
- FDA classification
- Class II
- Brand / firm
- Medtronic Sofamor Danek USA Inc
- Sold / distributed
- US Distribution to the state of : OK and to the countries of : Italy, Germany, France , Belgium, Spain and Japan.
Why it was recalled
Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
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