Stryker Tornier Shoulder Implant Insert May Not Seat Securely
Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.
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 with a manufacturing/assembly defect affecting an implantable shoulder component. While no injuries have been reported to date, the structural defect (inverted locking ring preventing secure seating) presents a risk of implant malfunction in a high-risk device. Per the severity rubric, this qualifies as 'risk-of-harm products where injury has not yet been reported,' scoring 3 (High).
Plain-English summary
Tornier Inc. is recalling 38 units of the Stryker Tornier Perform Humeral System Reversed Insert (model REF DWP2393, 45% configuration) used in shoulder replacement surgery. The affected devices are from Batch Lot #1495AY and were distributed nationwide throughout the United States.
The recalled implant components contain a locking ring that was installed upside down during manufacturing. This assembly defect prevents the humeral insert from seating securely against the stem or spacer, potentially compromising the stability and function of the shoulder implant.
Orthopedic surgeons, hospitals, and patients who received implants from this lot should contact Tornier Inc. immediately. Healthcare providers should identify patients with affected implants and work with the manufacturer to determine whether revision surgery or clinical monitoring is necessary.
The recalled product
- Product
- Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
- Manufacturer
- Tornier, Inc
- Affected units
- 38
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)
- GTIN 00846832084494
- Batch Lot # 1495AY
Distribution
Distributed nationwide across the United States.
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