OSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts
Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II device with missing critical structural components. While no illnesses or injuries have been reported, the missing bolts directly prevent proper device assembly and will require extended surgery to resolve. This represents a significant risk of surgical complication without confirmed patient harm.
Plain-English summary
Biomet, Inc. is recalling OSS Modular Arthrodesis Nails (Item Number CP260602) due to a manufacturing defect. Some units have been shipped missing the four small locking collar bolts, which are critical components for proper assembly and function of the device.
The missing bolts will be discovered during surgical use, requiring surgeons to locate a replacement and extend the operating time. Healthcare facilities that received affected units (Lot 136620) should immediately quarantine them and not use them for patient procedures. Contact Biomet if you have received affected units.
The recalled product
- Product
- OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
- Manufacturer
- Biomet, Inc.
- Affected units
- 2
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)
- UDI: (01)00880304082991(17)321103(10)136620 Lot Number: 136620
Distribution
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 Assemblies Recalled Due to Potential 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 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
Same hazard · missing components
See all →- SevereBaxter Spectrum IQ Infusion System may have missing motor mounting screws
FDA (Devices) · 2025-03-12
- LowHeartSine Samaritan PAD Defibrillator Shipped Without Battery and Pads
FDA (Devices) · 2022-03-16
- ModerateFungitell Kit Recalled for Missing or Incorrect Components
FDA (Devices) · 2019-05-22
- ModerateAbbVie Recalls PEG Kits Due to Missing or Duplicate Components
FDA (Devices) · 2017-06-07
- ModerateAbbVie Recalls PEG Kits Due to Missing or Duplicate Components
FDA (Devices) · 2017-06-07
Similar recalls
- ModerateZimmer Biomet Recalls Orthopedic Salvage System Locking Collars
FDA (Devices) · 2018-05-02
- HighBiomet Recalls OSS Knee Reamer Sleeves Due to Sticking Defect
FDA (Devices) · 2012-12-12
- HighBiomet Recalls OSS Knee Reamer Sleeves Due to Sticking Risk
FDA (Devices) · 2012-12-12
- HighOrthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction
FDA (Devices) · 2023-02-22
- ModerateOrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk
FDA (Devices) · 2019-11-06
- SevereZimmer Biomet Recalls Antegrade Femoral Nail Instrument Kits
FDA (Devices) · 2018-03-07