12.08.2014
The company has requested that hospitals using the component in operations locate and discontinue the use of the implant.
There are concerns that lot 3072321 of the Mallory Head HA/PC acetabular shell were manufactured without an HA coating, which is designed to enhance bone growth into the porous layer of the acetabular implant.
Biomet UK Ltd has urged hospitals using the component in total hip replacement procedures to make all staff aware of the issue, which was identified following a complaint, and to withdraw the affected implants from use.
The company noted that those unfamiliar with the HA Coated Mallory-Head Shell would not easily notice that the implant has been manufactured without the required coating.
A Manufacturing Error Led To The Fault With The Component
A field safety corrective action has been initiated by Biomet UK Ltd concerning its M-H 6 Hole Shell HA/PC implant used in hip replacements.The company has requested that hospitals using the component in operations locate and discontinue the use of the implant.
There are concerns that lot 3072321 of the Mallory Head HA/PC acetabular shell were manufactured without an HA coating, which is designed to enhance bone growth into the porous layer of the acetabular implant.
Biomet UK Ltd has urged hospitals using the component in total hip replacement procedures to make all staff aware of the issue, which was identified following a complaint, and to withdraw the affected implants from use.
The company noted that those unfamiliar with the HA Coated Mallory-Head Shell would not easily notice that the implant has been manufactured without the required coating.
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