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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable SpetzlerMalis Bipolar forceps

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  Class 2 Device Recall Disposable SpetzlerMalis Bipolar forceps see related information
Date Initiated by Firm September 11, 2023
Date Posted November 07, 2023
Recall Status1 Open3, Classified
Recall Number Z-0248-2024
Recall Event ID 93211
510(K)Number K121426  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Code Information GTIN: 7613327300185; Lot Numbers: 200924012, 201001029, 201022005, 201029006
Recalling Firm/
Manufacturer		 Stryker Corporation
1941 Stryker Way
Portage MI 49002-9711
For Additional Information Contact Jordan Anderson
269-800-1347
Manufacturer Reason
for Recall		 An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
FDA Determined
Cause 2		 Under Investigation by firm
Action An URGENT Medical Device Recall notification letter was sent to customers on 9/11/23. Actions to be taken 1. Immediately check your inventory to locate and quarantine any affected products found at your facility. 2. Sign and return the enclosed Business Response Form (BRF) by email to Instruments.recalls@stryker.com, even if affected product is no longer in inventory. 3. Upon receipt of the completed BRF, a shipping label will be provided to return any recalled product on-hand and Stryker will contact you to arrange for replacement of your product(s). 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. Please contact Jordan Anderson at (269) 800-1347 or Instruments.recalls@stryker.com with questions or concerns. For reporting any serious adverse events or product quality problems contact Stryker at 1-800-253-3210, ext. 5555 8:00 A.M. to 7:00 P.M. (Eastern Time), Monday Friday or by email at inst.stryker.cs@stryker.com.
Quantity in Commerce 2,321 total units
Distribution US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = SYNERGETICS, INC
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