510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0248-2024Class II

Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005

Stryker Corp. / initiated 2023-09-11 / Open, Classified / root cause: labeling and UDI
FDA source (opens on fda.gov)

Stryker Corporation began a recall of Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0248-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Stryker Corp.
Product
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
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.
Root cause tag
labeling and UDI
FDA root cause
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 [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].
Quantity in commerce
2,321 total units
Distribution
US Nationwide. Australia, Canada, Japan, Korea, Singapore.
Product codes and lots
GTIN: 7613327300185; Lot Numbers: 200924012, 201001029, 201022005, 201029006

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0248-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0239-2024Class IIOngoingVoluntary: Firm initiated
Z-0240-2024Class IIOngoingVoluntary: Firm initiated
Z-0241-2024Class IIOngoingVoluntary: Firm initiated
Z-0242-2024Class IIOngoingVoluntary: Firm initiated
Z-0243-2024Class IIOngoingVoluntary: Firm initiated
Z-0244-2024Class IIOngoingVoluntary: Firm initiated
Z-0245-2024Class IIOngoingVoluntary: Firm initiated
Z-0246-2024Class IIOngoingVoluntary: Firm initiated
Z-0247-2024Class IIOngoingVoluntary: Firm initiated
Z-0248-2024Class IIOngoingVoluntary: Firm initiated
Z-0249-2024Class IIOngoingVoluntary: Firm initiated
Z-0250-2024Class IIOngoingVoluntary: Firm initiated
Z-0251-2024Class IIOngoingVoluntary: Firm initiated
Z-0252-2024Class IIOngoingVoluntary: Firm initiated
Z-0253-2024Class IIOngoingVoluntary: Firm initiated
Z-0254-2024Class IIOngoingVoluntary: Firm initiated
Z-0255-2024Class IIOngoingVoluntary: Firm initiated
Z-0256-2024Class IIOngoingVoluntary: Firm initiated
Z-0257-2024Class IIOngoingVoluntary: Firm initiated