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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62575

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

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Event summary

Timeline bucket
July 11, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Straumann USA, LLC

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.

How coverage and grouping work

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

Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.

Z-2161-2012
Recall number
Z-2161-2012
Initiated
July 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Straumann USA, LLC
Quantity
14 Distributed in US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect Screw (RC) included with NC CARES Abutment Set was not a Narrow CrossFit (NC) Screw for CARES NC Abutment ZrO2

Code information

26217US_10008_00_b00; 25262US_10115_00_b05; 25262US_10115_00_b06; 21408US_10073_00_b01; 26199US _10021_00_b00; 25143US_ 10215_00_ b01; 25267US_10278- 00_ b01; 25267US _10280_ 00_b01; 25267US_ 1280_ 00_b03; 25310US_10342_03_b01; 25310US_10342_03_b03; 25310US_10342_03_b05; 25310US_10345_00_b01; 26249US_10019_00_b01;

Distribution pattern

US Nationwide Distribution including the countries of FL, IN, LA, NY and TX.