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Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - ...

FDA Device Recall #Z-0498-2019 — Class II — June 19, 2018

Recall Summary

Recall Number Z-0498-2019
Classification Class II — Moderate risk
Date Initiated June 19, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Sustainability Solutions
Location Tempe, AZ
Product Type Devices
Quantity 4848

Product Description

Reprocessed Xcel Bladeless Trocar (H12LP) Model # H12LP Reprocessed Endoscopic Trocars12x100mm - Product Usage: Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures. Physical Product Description: The Reprocessed Blunt Tip Trocar consists of a radiolucent cannula and obturator sized 12mm in diameter (refer to Figure 1). The Reprocessed Blunt Tip Trocar has an obturator that has a blunt plastic tip that gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The trocar cannula consists of two seals, an outer integrated removable self-adjusting seal that may accommodate instruments ranging from 5mm to 12mm in diameter, and an internal seal. These seals minimize gas leakage when instruments are inserted or withdrawn through the seal. The stopcock valve provides attachment for gas insufflation and desufflation. The stability plug component, is specific only to the H12LP catalog number. The stability plug (adjustable plug) is placed on the outside of the trocar sleeve (cannula). The stability plug provides suture clips (suture anchors), which can be used to suture the Trocar sleeve in place. Intended Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Reason for Recall

Through investigation, it was determined that H12LP Trocars in scope of a previous H12LP recall were distributed to facilities within the distribution chain following the recall execution activities initially performed by distributor.

Distribution Pattern

US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL. OUS: None.

Lot / Code Information

Lot Number 3727435 3732833 3732851 3752003 3762495 3762972 3765649 3783776 3775681 3779516 3782202 3784430 3786146 3794419 3803918 3810037 3811778 3809891 3821740 3829338 3833206 3834196 3853141 3854774 3861804 3863303 3870240 3873578 3881364 3886277 3866398 3890070 3890089 3880942 3894678 3896022 4113667 4118604 4133825 3849330 4138769 4147801 4154685 4158429 4170275 4173170 4187693 4198853 4202332 4235633 4245630 4274018 4282444 4386368 4515596 4459232 4458288 4466644 4467337 4466103 4473956 4474932 4476349 4477829 4479578 4512285 4513266 4530457 4533116 4548738 4551779 4557026 4566912 4572487 4571871 4574911 4576443 4576086 4577407 4581177 4580431 4583936 4589373 4593587 4603588 4597997 4602957 4598476 4607573 4608496 4608514 4615536 4609747 4610175 4610894 4611167 4611179 4612670 4613359 4614603 4618135 4615246 4616746 4659568 4659478 4660191 4671055 4662392 4663276 4664364 4668273 4669208 4672293 4670712 4667846 4668260 4668287 4670139 4674512 4674857 4074165 4672065 4680853 4681245 4683268 4686942 4688031 4688326 4688887 4688894 4690786 4695707 4704437 4698746

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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