Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Recall
- Recall Number
- Z-0973-2019
- Event Number
- 82063
- Firm
- Stryker Sustainability Solutions
- FEI Number
- 3009350690
- Product Code
- HRX
- Status
- Terminated
- Root Cause
- Software Design Change
- Initiated
- July 27, 2018
- Terminated
- September 17, 2020
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327
Description
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
Affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on CORE generators, or display an error message on Crossfire 1 and 2 generators which does not allow the device to be used.
On July 26, 2018, Stryker Sustainability Solutions sent an "URGENT MEDICAL DEVICE RECALL" Customer Notification Letter to affected consignees asking them to follow the instructions in the letter. The letter also included a risk evaluation these devices may pose to end users and their patients. According to the Urgent Medical Device Recall Customer Notification Letter there are no harms associated with the use of affected reprocessed arthroscopic shavers. 1) Noncompatible devices are rendered inactive with console and alternative surgical methods are readily available. 2) Incorrect spin speed does not result in any harm to the patient The letter also informed customers to; 1) discontinue use of affected reprocessed arthroscopic shavers; 2) complete the recall effectiveness check form and indicate if any of the affected product remains in their inventory; 3)Return the completed form either via e-mail to [email protected] or to their Stryker Sustainability Solutions sales rep, or via fax to 480.763.5345; 4) If no product is in inventory customers are also being told to complete the recall effectiveness check form and send in as described above; 5) finally any adverse events or quality problems experienced with the use of this product should be reported to: The FDAs MedWatch Adverse Event Reporting program either online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home, by regular mail or by fax; Strykers Sustainability Solutions division complaint hotline: +1 888 763 8803 or http://www.stryker.com/productexperience
Nationwide Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. OUS Israel and Canada.
14,265 units