CLASS II ONGOING Device recall · Reported 26 Oct 2022 · FDA Enforcement Report
Speed 15X12X12mm Continuous Compression Implant, Product No. SE recalled
Synthes (USA) Products is recalling Speed 15X12X12mm Continuous Compression Implant, Product No. SE-1512, distributed nationwide in the US. The recall was initiated on 27 Sep 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0099-2023
- FDA event ID
- 90918
- Recalling firm
- Synthes (USA) Products, West Chester, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Sep 2022
- FDA classified
- 18 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 27 Sep 2022 | Recall initiated by company | |
| 18 Oct 2022 | Classified by FDA | +21 days |
| 26 Oct 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.
Which lots are affected?
UDI-DI (GTIN): 00810633020166 Lot/Expiry MSE220445 7/1/2027 MSE210184 8/1/2026
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90918This product is part of a recall event; the main page for the event is Speed 9X10X10mm Continuous Compression Implant, Product No. SE recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Speed 9X10X10mm Continuous Compression Implant, Product No. SE recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | DePuy Synthes Hammertoe Continuous Compression Implants recalled | Synthes (USA) Products | Sterility | Nationwide | |
| CLASS II | SPEEDSHIFT20x20x20 Offset Implant Drill Kit, Product No. SE recalled | Synthes (USA) Products | Sterility | Nationwide |
More recalls from Synthes (USA) Products
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|---|---|---|---|---|---|
| Device | CLASS II | 2.4 Volt(tm) Tap Cortex Screw recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | 2.4 Volt Tap Locking Screw Tap recalled by Synthes (USA) Products | Synthes (USA) Products | Other | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Low Prof Lckng Screw, F/im Nail / L / Xl25/ Ster recalled | Synthes (USA) Products | Packaging Defects | Nationwide |
| Device | CLASS II | Stardrive Scrwdrvr Shft/T4/Self-retaining/Hxc-Intended recalled | Synthes (USA) Products | Other | Nationwide |
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