Biomet Recalls Offset Tibial Tray Adaptors Due to Sizing Issue
Biomet is recalling 200 offset tibial tray adaptors because the locking insert may not engage the tool, potentially delaying surgery and increasing anesthesia time.
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 involves a risk-of-harm product (medical device) where the defect could lead to increased anesthesia time, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 200 units of the Offset Tibial Tray 2.5 mm Adaptor (Catalog Number 141490). The affected lots are 378330, 378320, 407230, 485010, 505140, 485000, 506070, 533400, 54048, 439700, and 797820. These sterile knee joint replacement components were distributed worldwide, including in the United States, Australia, Canada, Chile, Europe, Japan, Korea, Panama, Puerto Rico, and Thailand.
The recall was initiated after Biomet's investigation identified that the square end of the adaptor's locking insert is oversized. This defect may prevent the insert from engaging with the insert tool screwdriver. If the tool cannot engage, it could cause a delay in surgery of more than 30 minutes. Such a delay potentially exposes the patient to increased risks associated with being under anesthesia for a longer duration.
No specific instructions for consumers are provided in the source text, as these are medical devices used by healthcare professionals during surgery. Healthcare providers should check their inventory for the specific catalog and lot numbers listed above and contact Biomet for further instructions.
The recalled product
- Product
- Biomet Offset Tibial Tray 2.5 mm Adaptor, REF 141490 Sterile, QTY.1 Product Usage: Knee joint replacement prostheses intended for application with or without bone cement. Knee joint replacement components include femoral, tibial, and patellar components, intended for both pr
- Manufacturer
- Biomet, Inc.
- Affected units
- 200
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 (11)
- Catalog Number: 141490 Lot 378330
- 378320
- 407230
- 485010
- 505140
- 485000
- 506070
- 533400
- 54048
- 439700
- 797820
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · surgical delay
See all →- HighAnti-Torque Instrument in Vector Pedicle Screw System Recalled
FDA (Devices) · 2026-08-12
- ModeratePhasor neurosurgical drills may have a reverse battery orientation
FDA (Devices) · 2025-08-06
- HighShoulder Prosthesis Stem Excess Material Prevents Proper Surgical Assembly
FDA (Devices) · 2025-03-26
- HighAnatomic lateral fibula plate locking screw failure during surgery
FDA (Devices) · 2025-03-05
- HighOrthopedic fibula plate locking screw failure during surgery
FDA (Devices) · 2025-03-05