Toby Orthopaedics Recalls PANTERA Proximal Humerus Fracture Plate System
Toby Orthopaedics is recalling PANTERA Proximal Humerus Fracture Plate Systems because suture clips may break during surgery.
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: The recall is classified as FDA Class II and involves a risk-of-harm product (implanted medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Toby Orthopaedics, Inc. is recalling 1,700 PANTERA Proximal Humerus Fracture Plate Systems. The recall is due to a potential for suture clips to break during a humerus fixation surgery.
The affected devices were distributed in the United States, Puerto Rico, Spain, Italy, Panama, Chile, Argentina, and Australia. The recall covers implanted plates with specific catalog numbers (TO-PHP series) distributed between November 26, 2010, and September 9, 2015, depending on the region.
This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific injuries or illnesses associated with this defect.
The recalled product
- Product
- PANTERA Proximal Humerus Fracture Plate System
- Manufacturer
- Toby Orthopaedics, Inc.
- Affected units
- 1,700
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 (20)
- TO-PHP-R73
- TO-PHP-L83
- TO-PHP-R83
- TO-PHP-L120
- TO-PHP-R120
- TO-PHP-L160
- TO-PHP-R160
- TO-PHP-L180
- TO-PHP-R180
- TO-PHP-L220
- TO-PHP-LS
- TO-PHP-RS
- TO-PHP-LE
- TO-PHP-RE
- 2. All implanted plates in Spain and Italy from 11/26/10 to 03/26/2014
- with catalog numbers TO-PHP-L73
- 3. All implanted plates in Panama from 11/26/10 to 05/27/2014
- TO-PHP-RE 4. All implanted plates in Puerto Rico
- Chile and Argentina from 11/26/10 to 04/11/2014
- 5. All implanted plates in Australia from 11/26/10 to 09/09/2015
Distribution
Related recalls
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- ModerateMiami Device Solutions Recalls Right Proximal Humerus Plates Due to Identification Error
FDA (Devices) · 2019-12-11
- ModerateBiomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design Files
FDA (Devices) · 2020-06-17
- ModerateBiomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies
FDA (Devices) · 2020-06-17
- ModerateBiomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues
FDA (Devices) · 2020-06-17
- ModerateBiomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
FDA (Devices) · 2020-06-17
- ModerateBiomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies
FDA (Devices) · 2020-06-17