Class 2 Device Recall Reprocessed Xcel Bladeless Trocar (H12LP)

• Date Initiated by Firm: June 19, 2018
• Create Date: November 27, 2018
• Recall Status: Open, Classified
• Recall Number: Z-0498-2019
• Recall Event ID: 81430
• 510(K)Number: K062497
• Product Classification: Laparoscope, general & plastic surgery, reprocessed - Product Code NLM
• Product: 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 These seals minimize gas leakage when instruments are inserted or withdrawn through the seal.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 These seals minimize gas leakage when instruments are inserted or withdrawn through the seal.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.
• 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
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• Manufacturer 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.
• FDA Determined Cause: Other
• Action: On June 29, 2018, the firm emailed an Urgent Medical Device Recall Notification to customers informing them that the firm is voluntarily recalling specific lots of the reprocessed Xcel blunt tip trocar, item number H12LP that were previously recalled under Product Field Action Z-0765-2017 initiated on 11/2/16. It has been identified through complaints that recalled product was actively distributed within the O&M network after initiation of Product Field Action Z-0765-2017. PLEASE DISTRIBUTE THIS INFORMATION TO ALL PERSONNEL RESPONSIBLE FOR REPROCESSED H12LP XCEL BLUNT TIP TROCAR. Item No: H12LP Please note: Only devices distributed from SSS to O&M from the affected lots are in scope. The affected lots were distributed from SSS to O&M from June 29, 2015 August 15, 2016. Affected Lot Numbers are: 3727435 3811778 3890089 4245630 4530457 4597997 4616746 4672293 3732833 3821740 3894678 4274018 4533116 4598476 4618135 4674512 3732851 3829338 3896022 4282444 4548738 4602957 4659478 4674857 3752003 3833206 4074165 4386368 4551779 4603588 4659568 4680853 3762495 3834196 4113667 4458288 4557026 4607573 4660191 4681245 3762972 3849330 4118604 4459232 4566912 4608496 4662392 4683268 3765649 3853141 4133825 4466103 4571871 4608514 4663276 4686942 3775681 3854774 4138769 4466644 4572487 4609747 4664364 4688031 3779516 3861804 4147801 4467337 4574911 4610175 4667846 4688326 3782202 3863303 4154685 4473956 4576086 4610894 4668260 4688887 3783776 3866398 4158429 4474932 4576443 4611167 4668273 4688894 3784430 3870240 4170275 4476349 4577407 4611179 4668287 4690786 3786146 3873578 4173170 4477829 4580431 4612670 4669208 4695707 3794419 3880942 4187693 4479578 4581177 4613359 4670139 4698746 3803918 3881364 4198853 4512285 4583936 4614603 4670712 4704437 3809891 3886277 4202332 4513266 4589373 4615246 4671055 3810037 3890070 4235633 4515596 4593587 4615536 4672065 The O&M distribution centers known to have received shipments of product in scope of this
• Quantity in Commerce: 4848
• Distribution: US nationwide distribution in the states of OK, GA, NJ, TX, IA, CO, TX, CA, LA, PA, VA, MD, WA, and IL. OUS: None.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NLM and Original Applicant = ASCENT HEALTHCARE SOLUTIONS