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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63559

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
September 20, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the lateral grasping arms to secure the implant. Once the implant is inserted and its position confirmed radiographically, the inserter is removed from the implant by turning the shaft knob counterclockwise to loosen the lateral grasping arms from the implant.

Z-0659-2013
Recall number
Z-0659-2013
Initiated
September 20, 2012
Classification
Class II
Status
Terminated
Recalling firm
Zimmer, Inc.
Quantity
170

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

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Inspect official wording and provenance

Reason for recall

Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient with the implant still engaged. The correction includes revised directions explaining the technique to remove the implant

Code information

Part number: 96-701-10001; Lot numbers: 61946711, 61946712, 61991588, 62000412,

Distribution pattern

USA nationwide; Europe, Sweden