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Signature Ceramic Femoral Head. Model Number: 111-152-621 recallZ-0920-2018 · Signature Orthopedics Pty Limited · initiated Feb 2, 2018

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 Signature Orthopedics Pty Limited 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

This recall has been identified due to the batch being mislabeled, with the packaged component's size not corresponding to the label. Therefore, the product intended to be used for the procedure may not be included in the packaging resulting in surgical delay as replacement product is retrieved.

FDA root cause category: Labeling mix-ups

What the company is doing

Signature Orthopaedics notified customer(s) of the recall by sending an Urgent Medical Device Recall Letter dated February 2, 2018 via email. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Customer Acknowledgement Form and firm's Effectiveness Check Questionnaire.

Recall details

Recall number
Z-0920-2018
Status
Terminated
Initiated by the company
Feb 2, 2018
Recalling firm
Signature Orthopedics Pty Limited
Quantity
10
Product code
MEH
FDA submissions
K121297
Distribution
Worldwide Distribution - U.S. Nationwide and the country of Australia.

Product description

Signature Ceramic Femoral Head. Model Number: 111-152-621. The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta). The heads connect via a 12/14 taper to the stem trunnion, and articulates against the crosslinked UHMWPE liner within the Logical Acetabular Cups. Product Usage: Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for: Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis Inflammatory joint disease including rheumatoid arthritis Correction of functional deformity including congenital hip dysplasia Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Code information (models, lots, serial numbers)

UDI: 09348215001926. Lot:78560.

Devices named in this recall

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

Other devices under the same FDA submission

2 devices cleared under K121297 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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