9805 recallZ-1150-2017 · Stryker Leibinger GmbH & Co. KG · initiated Jan 3, 2017
Class II Terminated All recalls posted in February 2017
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Stryker Leibinger GmbH & Co. KG or your healthcare provider. The company's action is summarized under what the company is doing.
- 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 incorrect sterility status on the label, non-sterile products labeled as sterile
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1150-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 3, 2017
- Posted by the FDA
- Feb 8, 2017
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Quantity
- 619
- Product code
- GCY
- FDA submissions
- K833586
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Australia, Canada, Chile, Spain, South Africa and Taiwan.
Product description
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
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K833586 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MEDPOR 6648Stryker Leibinger GmbH & Co. KG · APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 76146).
- Z-1149-2017 · TerminatedQUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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