Z-1150-2017Class II

9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile)...

Name: Z-1150-2017 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile)...
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2017-01-03
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2017-01-03 / Terminated / root cause: labeling and UDI

FDA source

Stryker Leibinger GmbH & Co. KG began a recall of 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... on 2017-01-03. FDA classified it as Class II and gives the reason as "An incorrect sterility status on the label, non-sterile products labeled as sterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1150-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-03
Posted: 2017-02-08
Terminated: 2017-07-27
Recalling firm: Stryker Leibinger GmbH & Co. KG
Product: 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
Product code: GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Reason for recall: An incorrect sterility status on the label, non-sterile products labeled as sterile
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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.
Quantity in commerce: 619
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Product codes and lots: 9805 Orbital Volume Sizer Set with Tray (Non-sterile) Lot M1311023 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) Lot M1305001 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) Lot M1603004 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Lot M1603003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1150-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1149-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-08
Z-1150-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-15	2017-02-08

Product code GCY

K833586Class ITls Bulb Drainage SystemPorex Medical / cleared 1984-01-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)