device · product 1 of 1
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
- Recall number
- Z-0920-2018
- Initiated
- February 02, 2018
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Signature Orthopedics Pty Limited
- Quantity
- 10
App-derived interpretation
Labeling or packaging
mislabeled
Official device-enrichment evidence · Sourced
Labeling mix-ups
Inspect official wording and provenance
Reason for recall
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.
Code information
UDI: 09348215001926. Lot:78560.
Distribution pattern
Worldwide Distribution - U.S. Nationwide and the country of Australia.