CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

Medtech Rosa Spine 1.0.2 The device is intended recalled

Zimmer Biomet is recalling Medtech Rosa Spine 1.0.2 The device is intended for the spatial positioning and, distributed nationwide in the US. The recall was initiated on 27 Feb 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial #'s: SP16008

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1755-2017
FDA event ID: 76820
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 27 Feb 2017
FDA classified: 7 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

27 Feb 2017	Recall initiated by company
7 Apr 2017	Classified by FDA	+39 days
19 Apr 2017	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Unapproved change made by the supplier.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed with three dimensional imaging software provided that the required fiducial markers and rigid patient anatomy can be identified on 3D CT scans. The device is indicated for the placement of pedicle screws in lumbar vertebrae with a posterior approach.

Where it was distributed

Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.

Nationwide California District of Columbia Florida Illinois Kentucky Massachusetts Minnesota North Carolina New York Ohio Pennsylvania

Questions about this recall

Why was it recalled?

Unapproved change made by the supplier.

Which lots are affected?

Serial #'s: SP16008

Where was it sold?

Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 76820

Reported	Class	Recall	Company	Reason	Where
19 Apr 2017	CLASS II	Medtech Rosa Brain 3.0 The device is intended recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide

More recalls from Zimmer Biomet

All 873

Reported	Class	Recall	Company	Reason	Where
30 Dec 2020Device	CLASS II	Spinal Rod Cutter recalled by Zimmer Biomet	Zimmer Biomet	Other	Nationwide
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

Other Spinal Implants recalls

All 1,157

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline medical convenience kits, labeled as recalled	Medline Industries	Other	Nationwide