Biomet Ringloc Acetabular System Screws Recalled for Sterile Seal Breach
Biomet is recalling specific lots of Ringloc Acetabular System self-tapping bone screws because a breach in the sterile seal could lead to loss of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential loss of sterility in an implantable medical device, which presents a risk of harm, but the source text does not report any specific injuries, illnesses, or fatalities.
Plain-English summary
Biomet, Inc. is recalling specific lots of RINGLOC ACETABULAR SYSTEM self-tapping bone screws (item numbers 103531, 103533, 103534, and 103535). The recall involves 7,428 units distributed worldwide, including the United States, Argentina, Australia, Brazil, Canada, Chile, China, Costa Rica, EMEA, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore, and Taiwan.
The recall is being issued because specific lots of these sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to a loss of sterility for the device.
The affected lots are 259830, 259860, 259880, 259890, 259910, 259920, 260020, 260140, and 260160. These devices are used in hip and knee prostheses, including semi-constrained, cemented, and uncemented configurations. Healthcare providers and facilities should check their inventory for these specific item numbers and lot numbers.
The recalled product
- Product
- 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 (Met
- Manufacturer
- Biomet, Inc.
- Affected units
- 7,428
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lots 259830 259860 259880 259890 259910 259920 260020 260140 260160
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 16 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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