CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Comprehensive Total Shoulder System/Bio-Modular Choice recalled
Biomet is recalling Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, distributed nationwide in the US. The recall was initiated on 25 Nov 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0620-2021
- FDA event ID
- 86896
- Recalling firm
- Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Nov 2020
- FDA classified
- 17 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Surgical Instruments
Timeline
| 25 Nov 2020 | Recall initiated by company | |
| 17 Dec 2020 | Classified by FDA | +22 days |
| 23 Dec 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item number 406669 - Product Usage: Surgical instrument handle, non-torque-limiting.
Where it was distributed
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
Questions about this recall
Is Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System recalled?
Yes. Biomet recalled Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System on 25 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0620-2021.
Why was it recalled?
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.
Which lots are affected?
Lot numbers 253970 279180 417710 499280
Where was it sold?
Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Biomet
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|---|---|---|---|---|---|
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
| Device | CLASS II | Intramedullary Bone Saw Blade Assembly recalled by Biomet | Biomet | Sterility | IN |
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Sterility | Nationwide |