Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65166

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

Open FDA event record

Event summary

Timeline bucket
March 06, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Linvatec Corp. dba ConMed Linvatec

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

GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures

Z-1619-2013
Recall number
Z-1619-2013
Initiated
March 06, 2013
Classification
Class II
Status
Terminated
Quantity
60 each of both units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Incorrect blue/white suture was used.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect blue/white suture was used.

Code information

Product Number CFBC-4502, Lot #431437

Distribution pattern

US Distribution including the states of FL, KY, LA, MI, NC, and NY.