Recall StatusTerminated
Date Initiated2018-07-27
Date Terminated2020-09-17
Product Quantity14,265 units
Reason for Recall
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.
Firm Action
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
Root Cause
Software Design Change
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.