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Zimmer Hip and Shoulder Replacement Parts (2016-01-22)
- Starting date:
- January 22, 2016
- Posting date:
- February 8, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57038
Affected Products
A. CONTINUUM,TRILOGY,ALLOFIT,METASUL TAPER
B. METASUL FEMORAL HEAD
C. SIDUS STEM-FREE SHOULDER HUMERAL HEAD
Reason
In a follow-up correction, Zimmer Biomet is removing from the field a subset (from Zimmer GmbH) of highly polished implants that were packaged in a low density polyethylene (LDPE) bag with a potential to adhere to the implants. In September 2013, customers were asked to examine devices before use and return any showing signs of LDPE adhesion. At that time a new bag was introduced that resolves the issue and prevents the bag from adhering to the implants.
Affected products
A. CONTINUUM,TRILOGY,ALLOFIT,METASUL TAPER
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
- 00-8770-006-28
- 00-8770-007-32
- 00-8770-010-36
- 00-8770-011-40
- 00-8770-012-40
- 00-8770-016-40
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8,
Winterthur
8404
SWITZERLAND
B. METASUL FEMORAL HEAD
Lot or serial number
25657381P
2607439
2618962
2625382
2625925
2627484
2629374
2631721
2633988
2635169
Model or catalog number
00-8770-040-01
00-8770-040-02
00-8770-040-03
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8,
Winterthur
8404
SWITZERLAND
C. SIDUS STEM-FREE SHOULDER HUMERAL HEAD
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
01.04555.380
01.04555.400
01.04555.420
01.04555.440
01.04555.460
01.04555.480
01.04555.485
01.04555.500
01.04555.505
01.04555.520
01.04555.525
Companies
- Manufacturer
-
Zimmer GmbH
Sulzer Allee 8,
Winterthur
8404
SWITZERLAND