Reported Oct 17, 2012 · Terminated
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA,…
Medtronic Sofamor Danek USA Inc.
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: Medtronic Sofamor Danek USA Inc · 1800 Pyramid Place · Memphis, TN · 38132
Is this the product you have?
- PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503
- QTY1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used
- Lot codes and dates
- All lots except those starting with SY
- Amount recalled
- 247 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
This product could cause temporary or reversible health problems — stop using it.
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