Shoulder implant recalled due to excessive bacterial endotoxin
Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.
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: This is a Class II FDA recall of an implanted medical device. While no illnesses or injuries have been reported, elevated bacterial endotoxin levels on a shoulder implant present a theoretical risk of post-surgical infection, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus implant, used in shoulder arthroplasty procedures. The affected lot, 3268BA, contains 5 units and was distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.
The recalled implant may exceed the specification for bacterial endotoxin load, with a maximum allowable limit of 20 EU/device. Elevated bacterial endotoxin levels on implanted medical devices increase the risk of infection at the surgical site or systemic infection.
Healthcare providers and patients who may have received this implant should monitor for signs of infection, including fever, pain, swelling, or drainage at the surgical site. Anyone experiencing these symptoms should seek immediate medical attention.
The recalled product
- Product
- stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
- Manufacturer
- Tornier, Inc
- Affected units
- 5
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 00846832092192
- Lot number 3268BA
Distribution
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