Surgical Implant Kit Recall: Incorrect Drill Guide Included
Synthes surgical implant kits are being recalled because they contain an incorrect size drill guide that cannot properly prepare the bone for the implant, creating a risk of bone damage 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: This is an FDA Class II medical device recall involving a functional defect (incorrect drill guide) that creates direct risk of bone damage during surgical implantation. No illnesses or injuries have been reported to date, placing it in the 'High' category as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling SPEED 15X12X12mm Continuous Compression Implant kits (Product No. SE-1512) distributed nationwide in the United States.
The kits contain an incorrect size drill guide. When used during surgical implantation, the incorrect drill guide will not properly prepare the bone for the implant size included in the kit. This creates a risk of bone damage due to incorrectly placed drill holes.
The affected lot numbers are MSE220445 (expiring 7/1/2027) and MSE210184 (expiring 8/1/2026). The recall impacts 94 units distributed in the United States and 30 units distributed outside the United States.
The recalled product
- Product
- SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
- Manufacturer
- Synthes (USA) Products LLC
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-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Synthes (USA) Products LLC 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Synthes (USA) Products LLC
See all →- HighVOLT locking screw taps swapped between lots carry incorrect thread
FDA (Devices) · 2026-04-08
- HighVOLT bone taps swapped between lots carry the incorrect thread
FDA (Devices) · 2026-04-08
- ModerateLocking bone screws recalled after packaging labeled with the wrong length
FDA (Devices) · 2025-10-29
- ModerateForty six millimetre locking screws recalled over wrong length on packaging
FDA (Devices) · 2025-10-29
- HighSurgical screwdrivers recalled for failure to engage with implant screws
FDA (Devices) · 2024-06-05
Same hazard · bone damage
See all →- HighSurgical retractor blade manufacturing defect could cause bone fracture
FDA (Devices) · 2024-07-10
- HighSurgical Anchor Inserter Tip Fragmentation During Patient Procedures
FDA (Devices) · 2023-06-14
- HighDePuy Mitek BIOKNOTLESS Plus Anchor Inserter Tip May Fracture During Surgery
FDA (Devices) · 2023-06-14
- HighDePuy Mitek surgical anchor inserter tip may fragment and be retained
FDA (Devices) · 2023-06-14
- HighDePuy Mitek surgical anchor inserter may fracture during use
FDA (Devices) · 2023-06-14
Similar recalls
- HighSynthes Synapse SD Drill Guide Recalled for Incorrect Etching
FDA (Devices) · 2013-08-07
- HighHammertoe Continuous Compression Implant Kit Drill Pin Incompatibility
FDA (Devices) · 2022-10-12
- ModerateSynthes 1.1mm Drill Bit Recalled for Incorrect MR Safety Labeling
FDA (Devices) · 2016-07-20
- HighSynthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns
FDA (Devices) · 2024-03-13
- ModerateImplant Direct Sybron Recalls Guided Surgery Handle Kits Due to Dimensional Defect
FDA (Devices) · 2017-09-20
- HighSynthes Pull Reduction Device Recalled for Potential Intraoperative Breakage
FDA (Devices) · 2015-06-24