Food, drugs, devices › Synthes (USA) Products LLC
Device recall: SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous
Synthes (USA) Products LLC (West Chester, PA) initiated this device recall on 27 Sep 2022; FDA lists 4 product records under event 90918, classified Class II.
FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Synthes (USA) Products LLC has 72 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Synthes (USA) Products LLC, West Chester, PA.
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."
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0098-2023 | SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants for bone fixation and management of fracture and reconstructive surgery. | 81 | Class II | Ongoing | 26 Oct 2022 |
| Z-0099-2023 | SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512 | 94 US; 30 OUS | Class II | Ongoing | 26 Oct 2022 |
| Z-0100-2023 | SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910 | 96 | Class II | Ongoing | 26 Oct 2022 |
| Z-0101-2023 | DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001 | 196 | Class II | Ongoing | 26 Oct 2022 |
Context
Other enforcement events for Synthes (USA) Products LLC
All 72 events for Synthes (USA) Products LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.