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Triology Shell
- Starting date:
- November 2, 2012
- Posting date:
- November 26, 2012
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Audience:
- General Public (GP), Healthcare Professionals, Hospitals
- Identification number:
- RA-15896
Recalled Products
- Trilogy Shell without Holes
- Trilogy Acetabular Shell Uni-Holes
- Trilogy Open Polar Hole Shell"
Reason
Zimmer is amending a current recall (Recall no. 78209) to include additional devices affected by this action, after determining that the uni-holed configuration does not have an option for supplemental fixation, which was part of the exclusion criteria to bound the scope of the filed action. Affected devices may be slightly below the lower range of the specification for porosity.
Affected products
A. Trilogy Shell without Holes
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
00620004821, 00620005021, 00620005221, 00620005421, 00620005621, 00620005821, 00620006021, 00620006221, 00620006421, 00620006621
Companies
- Manufacturer
- Zimmer Inc.
B. Trilogy Acetabular Shell Uni-Holes
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
65620005021, 65620005221, 65620005421, 65620005621, 65620006021
Companies
- Manufacturer
- Zimmer Inc.
C. Trilogy Open Polar Hole Shell
Lot or serial number
61199849, 61237937, 61260645, 61397941
Model or catalog number
00620005024, 00620005224, 00620005424, 00620005624
Companies
- Manufacturer
- Zimmer Inc.