Date Initiated by Firm |
September 11, 2023 |
Date Posted |
November 07, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0241-2024 |
Recall Event ID |
93211 |
510(K)Number |
K121426
|
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
|
Product |
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005 |
Code Information |
GTIN: 7613327300284;
Lot Numbers: 201105002 |
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
|
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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
|