Use caution Medical device recall · FDA · Published February 21, 2019

Smith&Nephew SmartStitch PerfectPasser Connector Recall: Incorrect Jaw Dimensions Risk

Smith&Nephew recalls SmartStitch PerfectPasser Connector (REF # OM-8010) due to manufacturing error causing upper jaw to potentially disengage during use. Affected units have specific batch numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3000-2020Medical device Smith&Nephew ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmArthroCare Corporation7000 W William Cannon Dr Bldg 1 · Austin, TX 78735-8509

✎ GovInfoNow plain-language explainer

Smith&Nephew is recalling its SmartStitch PerfectPasser Connector (REF # OM-8010) because a manufacturing error may cause the upper jaw to detach during use. This poses a risk of injury if the device becomes disengaged while in operation. Read more at govinfonow.com/recall/68958-smith-nephew-smartstitch-perfectpasser-connector-recall-incorrect-jaw-dimensions-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68958-smith-nephew-smartstitch-perfectpasser-connector-recall-incorrect-jaw-dimensions-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-3000-2020

Cite this page

“Smith&Nephew SmartStitch PerfectPasser Connector Recall: Incorrect Jaw Dimensions Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68958-smith-nephew-smartstitch-perfectpasser-connector-recall-incorrect-jaw-dimensions-risk. Based on FDA recall #Z-3000-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3000-2020%22&limit=1).

The FDA announced on Feb. 21, 2019, that ArthroCare Corporation voluntarily recalled Smith&Nephew SmartStitch PerfectPasser Connectors due to a manufacturing error causing incorrect upper jaw dimensions that could detach during use. The agency issued recall number Z-3000-2020 for the Class II device.

How to tell if you have it

Brand: Smith&Nephew
Product: SmartStitch PerfectPasser Connector
REF #: OM-8010
UDI: 00817470006971
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

The hazard

The recall addresses a manufacturing error resulting in incorrect upper jaw dimensions. This defect could cause the upper jaw to potentially disengage or detach during use.

Context

GovInfoNow's records show ArthroCare Corporation has one other recall on record since Aug. 17, 2020, specifically the Speed Stitch Needle Cassette Recall dated that day due to a supplier error mixing raw materials. Other recent recalls of similar products include TMJ Bilateral Implants Recall (Feb. 11, 2026), Olympus HX-400U-30 Ligating Device Recall (Oct. 30, 2025), and Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025).

How to tell if you have this one

Check the product's batch number on the connector, which is listed in the recall (e.g., 1154857, 1179855, etc.). The device is prescription-only and has a specific UDI code (00817470006971).

Brand
Smith&Nephew
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Batch Number
Look for the batch number on the connector, which is listed in the recall (e.g., 1154857, 1179855, etc.).
Stop Using if Disengaged
If the upper jaw disengages or detaches during use, stop using the device immediately and contact your healthcare provider.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 3.5 years after the firm started it.

Feb 21, 2019Firm started the recall
Sep 21, 2020FDA classified it Class II
Sep 30, 2020Published in FDA’s Enforcement Report
Aug 17, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/68958-smith-nephew-smartstitch-perfectpasser-connector-recall-incorrect-jaw-dimensions-risk">Smith&amp;Nephew SmartStitch PerfectPasser Connector Recall: Incorrect Jaw Dimensions Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-3000-2020 (February 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3000-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.