ClearanceBrief
Recall Z-2645-2023 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue

Stryker Corporation

Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462

DateSep 28, 2023 (initiated Aug 23, 2023)
StatusOpen, Classified
ReasonExpired Product distributed
Root causeUnknown/Undetermined by firm
ActionOn August 23, 2023, Stryker issued an "Urgent Medical Device Recall Notification" to affected consignees via . Stryker asked consignees to take the following actions: Actions needed: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Check all inventory to determine if any devices from the affected product list are located at your facility. Response is required by September 30, 2023. 3. If affected product is found, quarantine and discontinue use of the recalled devices. Please complete the response form on Appendix A of this notice and return devic
Quantity96 units
DistributionUS Nationwide distribution in the states of NY, NC, GA, TN, KY, IL, UT, AZ, NM, CA.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K131769CINCHLOCK KNOTLESS SUTURE ANCHOR, NANOTACK SUTURE ANCHOR 1.4MM
Pivot Medical, Inc., Oct 7, 2013