The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0038-2013·Announced 2012-10-17

Medtronic Premier Anterior Cervical Plate Screw Block Recall

Medtronic is recalling 247 units of the Premier Anterior Cervical Plate System Screw Block because gauge lines may be misaligned, potentially causing screws to be measured as 1 mm shorter than their actual length.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that could lead to improper surgical measurement (1 mm error), representing a risk of harm where injury has not yet been reported, consistent with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Medtronic Sofamor Danek USA Inc. is recalling 247 units of the PREMIER(R) Anterior Cervical Plate System SCREW BLOCK (REF 1860503). The recall affects all lots except those starting with SY. The product is an orthopedic instrument used for precision measurement and is distributed nationwide in the United States as well as in India, the Netherlands, Hong Kong, South Korea, Singapore, Canada, Australia, Japan, and Mexico.

The recall was initiated because lines on the screw gauge may not be placed on the caddy properly. This defect could result in improper measurement of screws, where an incorrect gauge might measure a screw to be approximately 1 mm shorter than its actual length.

Healthcare professionals and facilities that have received these devices should stop using them and contact Medtronic for instructions on return or replacement. Patients who have already had surgery using these instruments should contact their healthcare provider if they have concerns regarding their implant.

The recalled product

Product
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 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…
Manufacturer
Medtronic Sofamor Danek USA Inc
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
247

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots except those starting with SY

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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