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TaperFit Cemented Hip System recallZ-1667-2022 · Corin Ltd · initiated Jul 12, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Corin Ltd or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some of the devices did not pass fatigue testing.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1667-2022
Status
Terminated
Initiated by the company
Jul 12, 2022
Recalling firm
Corin Ltd
Quantity
1
Product code
JDI
FDA submissions
K142761
Distribution
Distribution was made to NJ. There was no military/government distribution.

Product description

TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.

Code information (models, lots, serial numbers)

Model #588.3800, Lot #494754; UDI 05055343871065

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K142761 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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