Class 2 Device Recall Karl Storz Powershaver System S2

• Date Initiated by Firm: October 11, 2024
• Date Posted: November 25, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0526-2025
• Recall Event ID: 95566
• 510(K)Number: K030009
• Product Classification: Arthroscope - Product Code HRX
• Product: 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x 5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x 5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x 6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x 4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x 5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x 5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x
• Code Information: Material Number: 28208BKS UDI-DI code: 04048551110751 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 88377N 89289N 89032N 89365N 89635N 89971N 90202N 93038N 91838N Material Number: 28206CBS UDI-DI code: Lot Numbers: 80066N 81369N 83233N 83478N 84444N 85877N 90894N Material Number: 28205NDS UDI-DI code: Lot Numbers: 83468N 84074N 83220N 84265N 84410N 85015N 84809N 85357N 86362N 87048N 91382N 93323N Material Number: 28205FDS UDI-DI code: Lot Numbers: 82968N 84246N 83460N 84416N 84440N 85352N 86057N 87456N 86361N 86091N 87049N 88223N 82233N 88755N 88491N 89902N 90702N 90200N 90531N 92248N 93022N 96143N 95045N Material Number: 28205HES UDI-DI code: Lot Numbers: 81806N 84978N 82127N 86078N 88756N 79745N 89950N 90679N 90911N 92548N-3 92548N-2 92548N-1 93707N 93027N 92955N 91032N 95051N 92995N Material Number: 28205GDS UDI-DI code: Lot Numbers: 82969N 83245N 84247N 84804N 85880N 85353N 87045N 90214N 86380N 90532N 93023N 91039N 95046N 95679N Material Number: 28208IDS UDI-DI code: Lot Numbers: 83236N 83268N 82133N 84447N 85362N 86364N 87863N 86807N 88483N 89033N 89024N 89905N 89679N 89959N 90913N 92551N-2 92552N-1 92552N-2 92551N-1 91318N 93033N 91381N 93086N 94862N Material Number: 28205HDS UDI-DI code: Lot Numbers: 83219N 83466N 84250N 85184N 84808N 86084N 86085N 86388N 86049N 87864N 88408N 88481N 88767N 89027N 89657N 89949N 89957N 90510N 91490N 93330N 93349N 91031N 90910N 91040N 93026N 93997N 93035N
• Recalling Firm/ Manufacturer: Karl Storz Endoscopy; 2151 E Grand Ave; El Segundo CA 90245-5017
• For Additional Information Contact: Mrs. Kathy Strange; 774-284-1736
• Manufacturer Reason for Recall: Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.
• FDA Determined Cause: Under Investigation by firm
• Action: On 10/28/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via UPS ground through a third party company (Sedgwick) to customers informing them that KARL STORZ has discovered a compromised sterile barrier during a visual inspection. Customers are instructed to: 1.Immediately quarantine and discontinue use of associated material numbers and associated lot numbers listed. 2.Pass on this Urgent Medical Device Recall to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 3.If you have or may have distributed the products listed, please identify and promptly notify those recipients, or provide KARL STORZ a list of customers who received/may have received the products listed. 4.Return the completed Customer Reply Form by Fax or E-Mail to the indicated contact below within 15 calendar days from the date of receipt. 5.Contact your KARL STORZ representative or call KARL STORZ Customer Support to return affected products. For Human Product: " Call Customer Support at 800-421-0837 Option 1 to set up an RMA. " Or call your KARL STORZ representative to assist with setting up an RMA. For Veterinary Product: " Call KSVEA Customer Support at 800-955-7832 Option 1 to set up an RMA. " Or email VetCustomerService@karlstorz.com 6. Please report any incidents related to this issue to the manufacturer, dealer, or local representative and, if applicable, to the national competent authority, as this is important feedback. If you have product to return, please contact KARL STORZ to set up an RMA. For Human Product Telephone: 800-421-0837 Option 1 For Vet Product Telephone: 800-955-7832 Option 1 For all other questions regarding this communication, please send an email to KSEAProductLabeling@karlstorz.com.
• Quantity in Commerce: 105 devices
• Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.
• 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 = HRX