Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63077

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 10, 2012
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

2 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 2

"***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.

Z-0383-2013
Recall number
Z-0383-2013
Initiated
April 10, 2012
Classification
Class II
Status
Terminated
Quantity
70 total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.

Code information

S8580 (8.0MM Drill Bit), lot numbers 322225 and 322226

Distribution pattern

Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.

device · product 2 of 2

"***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.

Z-0384-2013
Recall number
Z-0384-2013
Initiated
April 10, 2012
Classification
Class II
Status
Terminated
Quantity
70 total

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cannulated Drill Bit, lot numbers 322225 and 322226; and the S8585, 8.5MM SENTINEL Cannulated Drill Bit, lot number 322287. Recall was initiated due to the incorrect labeling on package.

Code information

S8585 (8.5MM Drill Bit), lot number 322287

Distribution pattern

Worldwide Distribution - USA including NJ, UT, GA, NY, PA, IL, LA, OH, CA, MS and Internationally to Canada, Japan, and Romania.