Tornier shoulder system parts mislabeled as compatible with the HRS Max
Tornier HRS Max tuberosity bodies and a trial component were incorrectly labeled as HRS Max products; they are compatible only with the Tornier HRS system. 233 units are affected.
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 recall where mislabeling could lead to an implant component being used with an incompatible system, a risk of harm with no injuries reported.
Plain-English summary
Tornier HRS Max parts are being recalled, including the HRS Max Tuberosity Body Lat Coat (Small, catalog number ARS1041101), the HRS Max Tuberosity Body No Coat (Small, catalog number ARS1041102) and the HRS Max Trial (catalog number ARS10252). The action covers 233 units.
The affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only and are incompatible with the Tornier HRS Max system. The FDA classified the action as Class II.
Distribution was nationwide in the United States, across a large number of states. The parts are supplied to healthcare facilities rather than sold to consumers.
Facilities should identify affected stock using the catalog numbers, UDI-DI (GTIN) codes and lot numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
- Manufacturer
- Tornier, Inc
- Affected units
- 233
Distribution
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