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U.S. Department of Health and Human Services

Class 2 Device Recall Sryker EVOLVE TRIAD Drill Guide

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 Class 2 Device Recall Sryker EVOLVE TRIAD Drill Guidesee related information
Date Initiated by FirmOctober 06, 2026
Date PostedNovember 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0447-2027
Recall Event ID 100069
Product Classification Guide, surgical, instrument - Product Code FZX
ProductSryker EVOLVE TRIAD Drill Guide REf: 49510109 Rxonly
Code Information UDI: 00889797016858/ Lot: 2567314 and 3350650
FEI Number 3010667733
Recalling Firm/
Manufacturer		 Wright Medical Technology, Inc.
11500 memphis arlington rd
arlington TN 38117-5423
For Additional Information ContactMeghan Wells
901-867-9971
Manufacturer Reason
for Recall		The drill guide was not manufactured to specification, which may result in the drill guide fracturing under less force than intended during use.
FDA Determined
Cause 2		Process design
ActionBetween the dates of October 6 - 14, 2026, Wright Medical Technology, Inc. ( subsidiary of Stryker) issued a Urgent Medical Device Recall notice via FedEx and email to affected consignees. Wright Medical ask consignees to take the following actions: 1. Immediately check your internal inventory to locate the product listed and remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Review the product issue and risks as communicated in this Recall Notice and communicate the issue as appropriate in your organization. 3. Sign and return the enclosed business reply form by email to Memphis.fieldaction@stryker.com a. Response is required, even if you may not have any physical inventory on site anymore. 4. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your affected product(s). 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. 6. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. b. If you are a distributor, note that you are responsible for notifying your affected customers. 7. Please inform us of any adverse events and/or report them to the Health/Competent Authorities in accordance with current regulations. 8. For questions or concerns, please contact memphis.fieldaction@stryker.com
Quantity in Commerce62 units
DistributionUS Nationwide distribution in the states of AZ, CA, CA, CO, CT, FL, IA, IL, ID, IN, KS, LA, MA, MI, MN, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TX, UT, VA, WA, WI.
Total Product Life CycleTPLC 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.
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