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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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
Related recalls
Same manufacturer · Tornier, Inc
See all →- HighTornier shoulder system parts mislabeled as compatible with the HRS Max
FDA (Devices) · 2026-04-15
- HighPeripheral screws recalled after a lot was labeled the wrong length
FDA (Devices) · 2026-02-11
- HighStryker Latitude EV Humeral Revision Stem Trial with Incorrect Marking
FDA (Devices) · 2025-04-30
- HighStryker Tornier Shoulder Implant Insert May Not Seat Securely
FDA (Devices) · 2024-10-09
- HighShoulder implant recalled due to excessive bacterial endotoxin
FDA (Devices) · 2024-09-25
Similar recalls
- HighTornier Recalls Aequalis Reversed II and Fracture Impactors
FDA (Devices) · 2013-09-25
- ModerateTornier Recalls Aequalis Ascend Flex Humeral Stems Due to Packaging Material Transfer
FDA (Devices) · 2019-11-20
- HighStryker Tornier Shoulder Implant Recalled for Device Packaging Mismatch
FDA (Devices) · 2024-01-31
- HighStryker Tornier Shoulder Implant Insert May Not Seat Securely
FDA (Devices) · 2024-10-09
- HighTornier Aequalis Pyrocarbon shoulder implants recalled for potential graphite exposure
FDA (Devices) · 2021-08-25
- HighShoulder prosthesis component distributed with incorrect thickness due to lot swap
FDA (Devices) · 2021-07-21