M/L Taper Reduced Neck Stems, M/L Taper Reduced Neck Extended Offset,M/L Taper with Kinectiv Stems,M/L Taper Standard Stems and M/L Taper Extended Offset Stems (2014-06-06)

Starting date:

June 6, 2014

Posting date:

June 18, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40067

• Reason
• Affected products

Recalled Products

A) M/L Taper Reduced Neck Standard Stems
B)  M/L Taper Reduced Neck Extended Offset
C) M/L Taper with Kinectiv Stems
D) M/L Taper Standard Stems
E) M/L Taper Extended Offset Stems

Reason

Zimmer has received eleven (11) complaints over a six-year timeframe that the sterile bag containing the implant contains a black residue, now identified as a combination of the titanium plasma spray used to create the porous surface of the implant and polyethylene bag containing the implant within the sterile package. All complaints were related to product that has been distributed through the loaner pool. Zimmer is therefore initiating a recall of m/l taper stems and m/l taper with Kinectiv stems that are in the loaner pool, and is suspending provision of these devices to the loaner pool.

Affected products