Synthes SPEED implant recall: drill guide size mismatch in surgical kit
Synthes is recalling SPEED 9X10X10mm surgical implant kits nationwide due to an incorrect-size drill guide that will not properly prepare bone for the implant, creating potential for bone damage.
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 medical device recall with potential for significant intraoperative bone damage. No illnesses or injuries have been reported, but the risk of bone damage from incorrect drill hole placement during surgery warrants High severity.
Plain-English summary
Synthes (USA) Products LLC has recalled the SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 (Lot MSE210240, expires 7/1/2027), distributed nationwide in the United States.
The product is being recalled because the sterile kit contains an incorrect-size drill guide. This drill guide will not properly prepare the bone for the size of the implant included in the kit.
If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant.
The recalled product
- Product
- SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 96
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): 00810633020111 Lot/Expiry MSE210240 7/1/2027
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.
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