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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73684

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

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Event summary

Timeline bucket
March 07, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Integra LifeSciences Corp.

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

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Z-1866-2016
Recall number
Z-1866-2016
Initiated
March 07, 2016
Classification
Class II
Status
Terminated
Quantity
30,146 Instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Code information

Catalogue No's: CEV649B5, CEV649BGP, CEV649GP, CEV8649B5, CEV8649BGP, CEV646B5, CEV647B5, CEV648B5, CEV649-5B, CEV649-5N, CEV8646B5, CEV8647B5, CEV8648B5, CEV1019-5B, CEV10195C, CEV10195D, CEV1019-5N, CEV10195NA, CEV10195R, CEV1039-5-B, CEV10395D, CEV1039-5N, CEV3911, CEV3931, CEV3941, CEV3951, CEV3961, CEV3981, CEV3991, CEV8991, CEV104M, CEV114M, CEV211, CEV220, CEV391B, CEV394B, CEV395B, CEV399B, CEV899, CEV405, CEV406, CEV407, CEV460, CEV470, CEV470-1, CEV511M, CEV514M, CEV515M, MCLP20, MCLP25, MCLP30, MCLP40, CEV8649GP, DEV9649B5, CEV9649BGP, CEV9649GP, CEV8649-5-B, CEV8649-5N, CEV9646B5, CEV9647B5, CEV9648B5, CEV9649-5-B, CEV9649-5N, CEV10395R, CEV1039G5, CEV618-5N, CEV6185R, CEV638-5N, CEV6385R, CEV720BR, CEV720R, CEV7285R, CEV605-5, CEV8911, CEV8931, CEV8941, CEV8951, CEV8961, CEV8981, CEV520M, CEV525M, CEV531-3, CEV815M, CEV891M, CEV894M, CEV895M, CEV995M, CEV996M, CEV997M, CEV998M, CM107, CM110, CM111, CM111R, CM112, CM113, CM115 and CM120. All batch numbers distributed from January 2011 to February 17, 2016.

Distribution pattern

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

device · product 2 of 2

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Z-1867-2016
Recall number
Z-1867-2016
Initiated
March 07, 2016
Classification
Class II
Status
Terminated
Quantity
2,487 Instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

Code information

Catalogue No: CEV669E. All batch numbers distributed from January 2011 to February 17, 2016.

Distribution pattern

AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI