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Terminated

9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants

FDA Recall Z-1150-2017 · Posted 2017-02-08

Recalling FirmStryker Leibinger GmbH & Co. KG
Recall StatusTerminated
Product CodeGCY
Date Initiated2017-01-03
Date Terminated2017-07-27
Product Quantity619

Reason for Recall

An incorrect sterility status on the label, non-sterile products labeled as sterile

Firm Action

Stryker sent an " URGENT MEDICAL DEVICE RECALL" notifications dated January 3, 2017, to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, instructions for returning affected product, and instructions for responding to the formal recall notification. Please report any adverse events or product quality problems to Stryker CMF Customer Service: 1 (800) 962-6558.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K833586TLS BULB DRAINAGE SYSTEMPorex Medical · 1984-01-30

Official Source

View FDA Recall →

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

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