Anatomic Locked Plating System 4 mm cancellous locking screws - used to treat broken bones

Hazard alert - risk of soft tissue irritation and potential need for revision

3 December 2015

Consumers and health professionals are advised that Zimmer Biomet, in consultation with the TGA, is issuing a hazard alert about Anatomic Locked Plating System (ALPS) 4 mm cancellous locking screws. The sponsor is also recalling unused stock of affected devices.

ALPS 4 mm cancellous locking screws are used with an orthopaedic fixation plate to treat broken bones.

Triple lead vs Single lead

It has been identified that all lots of ALPS 4 mm cancellous locking screws manufactured between 1 June 2008 and 4 June 2015 (see below for list of affected part numbers) have a single lead thread instead of a triple lead thread.

A single lead thread may 'sit proud' in the plate, meaning the head of the screw sits above the surface in which it is fixed. If this happens, soft tissue irritation may occur.

If the screw does not lock into the plate, it is possible for the screw to back out. If this happens, revision surgery to correct the problem may be necessary.

The affected part numbers are:

Part number Description
Non-sterile
816140010 CNLS Lock Screw FT 4.0x10mm
816140012 CNLS Lock Screw FT 4.0x12mm
816140014 CNLS Lock Screw FT 4.0x14mm
816140016 CNLS Lock Screw FT 4.0x16mm
816140018 CNLS Lock Screw FT 4.0x18mm
816140020 CNLS Lock Screw FT 4.0x20mm
816140022 CNLS Lock Screw FT 4.0x22mm
816140024 CNLS Lock Screw FT 4.0x24mm
816140026 CNLS Lock Screw FT 4.0x26mm
816140028 CNLS Lock Screw FT 4.0x28mm
816140030 CNLS Lock Screw FT 4.0x30mm
816140032 CNLS Lock Screw FT 4.0x32mm
816140034 CNLS Lock Screw FT 4.0x34mm
816140036 CNLS Lock Screw FT 4.0x36mm
816140038 CNLS Lock Screw FT 4.0x38mm
816140040 CNLS Lock Screw FT 4.0x40mm
816140042 CNLS Lock Screw FT 4.0x42mm
816140044 CNLS Lock Screw FT 4.0x44mm
816140046 CNLS Lock Screw FT 4.0x46mm
816140048 CNLS Lock Screw FT 4.0x48mm
816140050 CNLS Lock Screw FT 4.0x50mm
816140055 CNLS Lock Screw FT 4.0x55mm
816140060 CNLS Lock Screw FT 4.0x60mm
816140065 CNLS Lock Screw FT 4.0x65mm
816140070 CNLS Lock Screw FT 4.0x70mm
816140075 CNLS Lock Screw FT 4.0x75mm
816140080 CNLS Lock Screw FT 4.0x80mm
816140085 CNLS Lock Screw FT 4.0x85mm
816140090 CNLS Lock Screw FT 4.0x90mm
816140095 CNLS Lock Screw FT 4.0x95mm
816140100 CNLS Lock Screw FT 4.0x100mm

Information for consumers

There have been no reports of adverse events associated with the above issue. The probability of a problem occurring due to this issue is remote.

If you or someone you care for has had an orthopaedic fixation plate implanted to treat a broken bone and you have any questions or concerns about this issue, contact your surgeon or the hospital where the surgery was undertaken.

Information for all health professionals

If you are treating a patient who has had an orthopaedic fixation plate implanted to treat a broken bone and they are concerned about this issue, reassure them that there have been no reports of adverse events to date and the probability of a problem occurring due to this issue is remote.

However, if they experience symptoms of soft tissue irritation at the site of the implant or have any other questions or concerns about this issue, refer them to their surgeon or to the hospital where the surgery was undertaken.

Information for surgeons and hospitals

Zimmer Biomet has contacted surgeons who have implanted ALPS 4 mm cancellous locking screws and hospitals that hold stock of this product, providing further information regarding this issue, including details about the recall of unused stock.

If you have implanted ALPS 4 mm cancellous locking screws in a patient, advise them of this issue at their next follow-up visit. Inform them of the signs and symptoms of soft tissue irritation and instruct them to contact you if any are suspected.

Reassure them that there have been no reports of adverse events to date and the probability of a problem occurring due to this issue is remote.

Continue to monitor them. Otherwise, no further action is required at this time.

If you have any further questions or concerns about this issue, contact Zimmer Biomet on 02 9483 5400.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.