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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Tornier, Inc: Perform Reversed Glenoid Press-Fit Implants Recalled for Incorrect Device in Package

Agency Publication Date: January 19, 2024
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Summary

Tornier, Inc. is recalling 50 units of the Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post shoulder implant because the package contains the incorrect medical device. Using an incorrect surgical implant can lead to improper fit, device failure, or the need for revision surgery. These sterile, cementless implants were distributed in several U.S. states and internationally. Patients who have undergone shoulder surgery involving this specific implant should contact their healthcare provider to discuss any concerns.

Risk

The presence of an incorrect device within the labeled sterile packaging can lead to the implantation of a component that does not match the surgeon's intended specifications, potentially causing surgical delays or post-operative complications. No specific injuries have been reported in the available data.

What You Should Do

  1. Identify if you have the affected product by checking your medical records or packaging for the Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V (REF DWJ001, Length: 7mm).
  2. Verify the batch lot and serial numbers: Look for batch lot code 6714AZ and serial numbers ranging from 6714AZ001 through 6714AZ050.
  3. Check the GTIN barcode number on the product label to see if it matches 00846832091614.
  4. If you are a healthcare provider, immediately stop using and quarantine any remaining units from this specific batch and serial number range.
  5. If you are a patient and believe this device was used in your surgery, contact your surgeon or healthcare provider to confirm the integrity of your implant and discuss any necessary follow-up care.
  6. Contact Tornier, Inc. (Stryker) directly for instructions on returning affected products and to facilitate a replacement or further remedy.
  7. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact your healthcare provider or the manufacturer for further instructions and potential refund

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V (7mm)
Model / REF:
REF DWJ001
UPC Codes:
00846832091614
Lot Numbers (51):
6714AZ
6714AZ001
6714AZ002
6714AZ003
6714AZ004
6714AZ005
6714AZ006
6714AZ007
6714AZ008
6714AZ009
6714AZ010
6714AZ011
6714AZ012
6714AZ013
6714AZ014
6714AZ015
6714AZ016
6714AZ017
6714AZ018
6714AZ019
6714AZ020
6714AZ021
6714AZ022
6714AZ023
6714AZ024
6714AZ025
6714AZ026
6714AZ027
6714AZ028
6714AZ029
6714AZ030
6714AZ031
6714AZ032
6714AZ033
6714AZ034
6714AZ035
6714AZ036
6714AZ037
6714AZ038
6714AZ039
6714AZ040
6714AZ041
6714AZ042
6714AZ043
6714AZ044
6714AZ045
6714AZ046
6714AZ047
6714AZ048
6714AZ049

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93709
Status: Active
Manufacturer: Tornier, Inc
Sold By: Hospitals; Surgical Centers; Medical Device Distributors
Manufactured In: United States
Units Affected: 50
Distributed To: Arkansas, Arizona, California, Colorado, Connecticut, North Carolina, Ohio, Tennessee, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.