Stryker Tornier Reversed Glenoid Baseplate Recalled for Manufacturing Defect
One lot of Stryker Tornier Perform Reversed Glenoid Baseplate components was manufactured with incorrect 6mm spacers instead of 3mm, preventing proper assembly. The defect affects 30 units distributed across ten US states.
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 manufacturing defect in a surgical implant component that prevents proper assembly and function. No injuries or illnesses are reported in the source. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
The Stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate (25mm, Offset +3mm, REF DWJ502) is being recalled due to a manufacturing defect in one production lot.
One lot was manufactured with 6mm spacers instead of the correct 3mm spacers. This nonconformance prevents the central screw from threading into the baseplate. The defect affects proper assembly of the surgical implant.
The recall involves 30 units from Lot Number 1756123. These units were distributed to medical facilities in California, Colorado, Illinois, Massachusetts, Minnesota, North Carolina, Oregon, Rhode Island, South Carolina, and Tennessee.
The recalled product
- Product
- stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- Manufacturer
- Tornier, Inc
- Affected units
- 30
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 (2)
- UDI/DI 10846832062017
- Lot Number 1756123
Distribution
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