Normed Foot and Ankle Instruments - Drill, Tap, Countersink (2019-04-04)
- Starting date:
- April 4, 2019
- Posting date:
- May 3, 2019
- 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-69816
Last updated: 2019-05-03
Affected Products
A. Normed Foot and Ankle Instruments - Drill
B. Normed Foot and Ankle Instruments - Tap
C. Normed Foot and Ankle Instruments - Countersink
Reason
Zimmer GmbH is conducting a medical device recall for specific instruments formerly manufactured and marketed by Normed Medizin-Technik GmbH. All lots manufactured by this company are within the scope of this recall. Only instruments marked with the name/ logo "Normed" are subject to this removal action.
Zimmer Biomet received complaints reporting tip breakages. An investigation identifies that Normed Medizin-Technik GmbH possibly manufactured certain lots from a different material than defined in the applicable specifications. As a precautionary measure Zimmer Biomet has decided to remove the complete family of instruments that were manufactured by Normed Medizin-Technik GmbH prior to its manufacturing transfer to Zimmer Biomet in 2014.
Affected products
A. Normed Foot and Ankle Instruments - Drill
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
502015106
502015107
502015114
502015115
502015120
502015124
502015130
502015131
502015136
502015137
502015142
502015145
502015146
502015206
502015207
502015208
502015211
502015212
502015213
502015216
502015217
502015218
502015402
502015403
502015619
502015620
502015621
502015623
502015628
502015629
502015630
502015631
502015634
502015635
502015636
502015637
502015638
502015640
502015650
502015706
ST502015206
ST502015207
ST502015208
ST502015212
ST502015216
ST502015217
ST502015402
ST502015403
ST502015619
ST502015620
ST502015621
ST502015623
ST502015628
ST502015630
ST502015631
ST502015635
ST502015640
ST502015650
ST502015706
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8
Winterthur
8404
SWITZERLAND
B. Normed Foot and Ankle Instruments - Tap
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
503002041
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8
Winterthur
8404
SWITZERLAND
C. Normed Foot and Ankle Instruments - Countersink
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
28.66.110
28.66.111
28.66.112
28.66.113
503004177
503004341
503004342
503004351
503004352
503004353
503004541
503004542
ST28.66.111
ST28.66.113
ST503004541
ST503004542
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8
Winterthur
8404
SWITZERLAND