Recall Z-0526-2025 ยท HRX Arthroscope
Karl Storz Endoscopy
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 Ba
| Date | Nov 25, 2024 (initiated Oct 11, 2024) |
| Status | Open, Classified |
| Reason | Due to holes detected in the inner barrier system that may compromise the sterility of the affected products. |
| Root 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 product |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030009 | KSEA POWERSHAVER SYSTEM S2 Karl Storz Endoscopy, Apr 2, 2003 |