CLASS II Device recall · Reported 23 Dec 2020 · FDA Enforcement Report
Ringloc Acetabular System Self-tapping bone screws recalled by Biomet
Biomet is recalling Ringloc Acetabular System Self-tapping bone screws, 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-0627-2021
- 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
- Foreign Material
- Device type
- Hip & Knee Implants
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented; Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component); Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer.
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 Ringloc Acetabular System Self-tapping bone screws recalled?
Yes. Biomet recalled Ringloc Acetabular System Self-tapping bone screws on 25 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0627-2021.
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?
Lots 259830 259860 259880 259890 259910 259920 260020 260140 260160
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
All 279| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |