Stryker Tornier Shoulder Implant Recalled for Device Packaging Mismatch
Tornier, Inc is recalling 50 units of Stryker Tornier Perform shoulder implants because the incorrect device is contained in the labeled package. Affected batch: lot 6714AZ, serial 001–050.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a surgical implant with packaging mismatch. This constitutes a risk-of-harm product where the incorrect device in the labeled package could result in implantation error, though no injuries have been reported.
Plain-English summary
Tornier, Inc is recalling 50 units of Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V shoulder implants (REF DWJ001, 7mm, cementless sterile). The affected batch consists of lot code 6714AZ, serial numbers 001 through 050 (GTIN 00846832091614). The reason for the recall is that the incorrect device is contained in the labeled package.
The recalled units were distributed to healthcare facilities in Arkansas, Arizona, California, Colorado, Connecticut, North Carolina, Ohio, Tennessee, and Virginia in the United States. International distribution was made to Australia, France, and Italy. No military or government distribution occurred.
Patients or healthcare providers who may have received these devices should contact Tornier, Inc or their physician for guidance regarding this recall.
The recalled product
- Product
- Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
- Manufacturer
- Tornier, Inc
- Affected units
- 50
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Batch lot codes 6714AZ
- serial numbers 001 to 050: 6714AZ001
- 6714AZ002
- 6714AZ003
- 6714AZ004
- 6714AZ005
- 6714AZ006
- 6714AZ007
- 6714AZ008
- 6714AZ009
- 6714AZ010
- 6714AZ011
- 6714AZ012
- 6714AZ013
- 6714AZ014
- 6714AZ015
- 6714AZ016
- 6714AZ017
- 6714AZ018
- 6714AZ019
Distribution
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