- Z-0623-2021 ·Class II · terminated · 25 Nov 2020
Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.
- Z-2147-2020 ·Class II · terminated · 17 Apr 2020
Potential presence of elevated endotoxin levels that exceed the specification limit
- Z-2234-2019 ·Class II · terminated · 2 Jul 2019
Cleaning processes potentially being ineffective
- Z-2235-2019 ·Class II · terminated · 2 Jul 2019
Cleaning processes potentially being ineffective
- Z-2231-2019 ·Class II · terminated · 2 Jul 2019
Cleaning processes potentially being ineffective
- Z-2236-2019 ·Class II · terminated · 2 Jul 2019
Cleaning processes potentially being ineffective
- Z-2233-2019 ·Class II · terminated · 2 Jul 2019
Cleaning processes potentially being ineffective
- Z-2232-2019 ·Class II · terminated · 2 Jul 2019
Cleaning processes potentially being ineffective
- Z-0590-2019 ·Class II · terminated · 10 Oct 2018
Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.
- Z-0303-2018 ·Class II · terminated · 5 Jun 2017
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
- Z-0417-2012 ·unclassified · terminated · 1 Nov 2011
Biomet has initiated this action following an investigation which identified that Part 150367, (OSS
Cemented 1M Stem 13x150) was incorrectly labeled as part 150368 (OSS Cemented 1M Stem
14x150).
- Z-1526-2009 ·unclassified · terminated · 19 May 2009
The retaining ring may fall out of the instrument during surgery.
- Z-1528-2009 ·unclassified · terminated · 19 May 2009
The retaining ring may fall out of the instrument during surgery.
- Z-1531-2009 ·unclassified · terminated · 19 May 2009
The retaining ring may fall out of the instrument during surgery.
- Z-1529-2009 ·unclassified · terminated · 19 May 2009
The retaining ring may fall out of the instrument during surgery.
- Z-1530-2009 ·unclassified · terminated · 19 May 2009
The retaining ring may fall out of the instrument during surgery.
- Z-1527-2009 ·unclassified · terminated · 19 May 2009
The retaining ring may fall out of the instrument during surgery.
- Z-1881-2008 ·unclassified · terminated · 15 May 2008
Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.
- Z-1879-2008 ·unclassified · terminated · 15 May 2008
Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.
- Z-1880-2008 ·unclassified · terminated · 15 May 2008
Mislabeled--The product is not collared, although the label states that it is collared. A non-collared component will provide a reduced contact with bone interface and/or a delay in the procedure may be incurred while clarifying package contents.
Recalls matched to the 6 devices listed on this page; other pages of the family can carry others.