Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports
Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a Class II medical device with reports of component dislocation, which constitutes a significant injury risk and structural defect in a load-bearing implant.
Plain-English summary
Tornier, Inc. is conducting a recall of Aequalis Fx2 implant parts and instrument trays. The affected products include specific insert and stem components used for the total or partial replacement of the glenohumeral articulation.
The recall is being conducted due to reports of dislocations of the poly insert and the stem. The source text does not specify the number of affected units, the specific dates of distribution, or the number of patients affected.
Healthcare providers and patients who have received these specific implant parts should contact their surgeon or Tornier, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DW
- 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 (20)
- 0924AR
- 0809AR
- 1110AR
- 1290AR
- 0811AR
- 0151AR
- 2447AR
- 6082AQ
- 5935AQ
- 6373AQ
- 7153AQ
- 7532AQ
- 9966AQ
- 0018AQ
- 0385AR
- 0386AR
- 0384AR
- 3014AR
- 6892AQ
- 8250AQ
Distribution
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