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Spetzler-Malis recallZ-0256-2024 · Stryker Corporation · initiated Sep 11, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Under Investigation by firm

What the company is doing

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 [email protected], 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 [email protected] 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 [email protected].

Recall details

Recall number
Z-0256-2024
Status
Open, Classified
Initiated by the company
Sep 11, 2023
Posted by the FDA
Nov 7, 2023
Recalling firm
Stryker Corporation
Quantity
2,321 total units
Product code
GEI
FDA submissions
K121426
Distribution
US Nationwide. Australia, Canada, Japan, Korea, Singapore.

Product description

Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010

Code information (models, lots, serial numbers)

GTIN: 7613327300178; Lot Numbers: 200525014, 201015017, 201112017

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 93211).

Sources and updates

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