StageOne and StageOne Select Bone Cement Spacer Molds (2020-03-04)
- Starting date:
- March 4, 2020
- Posting date:
- April 15, 2020
- 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-72727
Last updated: 2020-04-15
Affected Products
- StageOne Hip Spacer Mold
- StageOne - Select Hip Spacer Mold Stem
- StageOne Hip Cement Spacer Mold
- StageOne Shoulder Cement Spacer Mold
- StageOne Knee Femoral Cement Spacer Mold
- StageOne Knee Tibial Cement Spacer Mold
Reason
Zimmer Biomet is conducting a medical device recall for StageOne and StageOne Select bone cement spacer molds. These devices were subject to a potentially insufficient cleaning process or to potentially inadequate process monitoring for cleaning parameters. For the more than 230,000 devices distributed, there have been five (5) global complaints for events associated with the risks. These devices are a single-use silicone mold intended to be filled with bone cement. Upon curing of the bone cement, a temporary bone cement spacer is created for patients undergoing a two-stage revision due to infection. The resulting bone cement spacer typically remains in place for less than six months with partial weight bearing until the second stage of the two-stage revision is performed to implant a conventional prosthesis.
Affected products
A. StageOne Hip Spacer Mold
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 431181
- 431182
- 431183
- 431184
- 431185
- 431190
- 431191
- 431192
- 431193
- 431194
- 431207
- 431209
- 431213
- 431217
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
B. StageOne - Select Hip Spacer Mold Stem
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 431195
- 431196
- 431197
- 431198
- 431199
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
C. StageOne Hip Cement Spacer Mold
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 431107
- 431109
- 431113
- 431117
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
D. StageOne Shoulder Cement Spacer Mold
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 31406
- 431408
- 431410
- 431412
- 431414
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
E. StageOne Knee Femoral Cement Spacer Mold
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 432160
- 432165
- 432170
- 432175
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES
F. StageOne Knee Tibial Cement Spacer Mold
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 433165
- 433170
- 433175
- 433180
Companies
- Manufacturer
-
Biomet Orthopedics
56 East Bell Drive, P.O. BOX 587
Warsaw
46581
Indiana
UNITED STATES