TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
- Recall Initiated
- July 12, 2022
- Recall Number
- Z-1667-2022
- Quantity
- 1
Reason for Recall
Some of the devices did not pass fatigue testing.
Distribution
Distribution was made to NJ. There was no military/government distribution.
Lot / Code Info
Model #588.3800, Lot #494754; UDI 05055343871065
Root Cause
Under Investigation by firm
Action Taken
The recalling firm issued the recall letter dated 7/8/2022 via email to the consignee on 7/12/2022. The recall letter described the potential issue and listed the affected product. The potential risk was reported and the actions to be carried out by the customer, which included return of the product from the field and completion of the acknowledgement form to be returned via email to confirm receipt of the letter.
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