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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85321

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

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Event summary

Timeline bucket
February 21, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ArthroCare Corporation

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

Smith&Nephew SmartStitch PerfectPasser Connector, REF # OM-8010, Rx Only, CE 0123, UDI: 00817470006971

Z-3000-2020
Recall number
Z-3000-2020
Initiated
February 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
ArthroCare Corporation
Quantity
15,559 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The voluntary recall is being initiated due to a manufacturing error resulting in incorrect upper jaw dimensions, and the upper jaw could potentially disengage or detach during use.

Code information

Batch Numbers: 1154857, 1179855, 1184077, 1194208, 2005153, 1154858, 1179856, 1184078, 1194763, 2005154, 1156429, 1179857, 1184825, 2001517, 2005251, 1165209, 1179858, 1184826, 2001518, 2005252, 1166194, 1179859, 1184827, 2001519, 2005494, 1168946, 1181657, 1184828, 2002828, 2006014, 1170928, 1181658, 1184829, 2002829, 2006037, 1170929, 1182577, 1184830, 2002830, 2006038, 1170930, 1182578, 1184831, 2002831, 2006039, 1170931, 1182579, 1185959, 2002832, 2006040, 1174530, 1182580, 1187253, 2004741, 1174531, 1182581, 1187254, 2004933, 1175357, 1182621, 1187255, 2004934, 1175401, 1182622, 1192014, 2005147, 1178577, 1184074, 1192015, 2005149, 1178578, 1184075, 1192016, 2005150, 1179854, 1184076, 1192017, 2005152

Distribution pattern

US: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, SC, SG, TN, TX, UT, VA, WA, WI, WV OUS: Austria, Belgium, Canada, Switzerland, Germany, Denmark, France, England, Ireland, India, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, Turkey, United Arab Emirates, South Africa)