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Terminated

QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium.

FDA Recall Z-2900-2018 · Posted None

Recall StatusTerminated
Product CodeGWO
Date Initiated2018-06-22
Date Terminated2019-07-08
Product Quantity22,831 total

Reason for Recall

After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised.

Firm Action

URGENT MEDICAL DEVICE RECALL letters dated 6/22/18 were sent to customers with the following requested actions to be taken: 1. Please inform users of this Medical Device Removal and pass this notice to all appropriate individuals within your organization. 2. Return all affected products available at your location to: Stryker CMF Attn: Recall Coordinator 6300 Sprinkle Rd Portage, MI 49002 REF: PFA #1739180 Or, Contact Stryker Customer Service and refer to PFA #1739180 with any questions about returning the product to us. 3. Complete and sign the enclosed Business Reply Form and fax a copy to: (877) 648-7114 or email a copy to [email protected]. 4. Keep a copy of the completed and executed Customer response Form for your records.

Root Cause

Package design/selection

Distribution Pattern

US distribution in the states: AZ, FL, NH, and OH, Australia, Canada, France, New Zealand, and UK.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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