Triathlon Tibial Alignment Handle

Starting date:

October 11, 2011

Posting date:

January 9, 2012

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-15118

• Reason
• Affected products

Recalled products

1. Triathlon Tibial Alignment Handle

Reason

Stryker  received a product experience report (PER) that a Swivel Block was improperly oriented on a Triathlon Tibial Alignment handle. The locator holes on the alignment guide handle on which the Swivel Block is mounted are not in alignment as per print. The Tibial Alignment handle was not machined properly on the 5 Axis machine because the Tibial Alignment handle was not fixtured properly on the machine by the operator. The fixturing procedure involved manually locating every part in a collet, aligning Datum C using a square and locking the part in position for machining of the slot and cross hole. Additionally, the particular feature was not inspected during in-process and/or final inspection at the vendor. Hence, the non-conformance was not detected.

Affected products