Speed ShiftRecalls & reported problems across all models
Synthes GmbH · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Speed Shift model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 6 models of Speed Shift by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 37 adverse event reports in the FDA's MAUDE database, received between Sep 4, 2018 and May 22, 2023 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Speed Shift recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 27, 2022Open, Classified
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.
Z-0098-2023 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported Speed Shift problems
Device problems
- Detachment of Device or Device Component17
- Break12
- Manufacturing, Packaging or Shipping Problem7
- Crack2
- Difficult to Advance1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Consequences Or Impact To Patient7
- No Patient Involvement5
- No Known Impact Or Consequence To Patient1
Speed Shift models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Speed Shift SE-2020-10Staple, Fixation, Bone1 recall10 reports
- Speed Shift SE-1520-08Staple, Fixation, Bone9 reports
- Speed Shift SE-1520-06Staple, Fixation, Bone8 reports
- Speed Shift SE-1520-10Staple, Fixation, Bone6 reports
- Speed Shift SE-2020-06Staple, Fixation, Bone2 reports
- Speed Shift SE-2020-08Staple, Fixation, Bone2 reports
Recent Speed Shift adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2023Break; Break
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING PRE-OP IT WAS NOTICED THAT THE PRODUCT HAS BROKEN IN THE BOX. THE PRODUCT HAS NOT BEEN OPENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16975966 ↗MalfunctionMar 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN SPAIN AS FOLLOWS: IT WAS REPORTED THAT WHILE CHECKING THE DEPOSIT ON AN UNKNOWN DATE IN 2023 IT WAS DISCOVERED THAT THE IMPLANTS HAVE COME LOOSE FROM THE INSERTERS INSIDE THE UNOPENED CONTAINER. THERE IS ONLY ONE LOOSE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 15X20X20 OFST 8. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16478881 ↗MalfunctionFeb 14, 2023Break; Break
THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16373598 ↗MalfunctionFeb 6, 2023Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE INSERTER WAS CRACKED WHEN RESTOCKING THE SPEED SHIFT TOTE. THERE WAS NO CONSEQUENCE TO A PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 6MM IMPLANT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16308679 ↗MalfunctionFeb 6, 2023Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED THAT THE INSERTER WAS CRACKED WHEN RESTOCKING THE SPEED SHIFT TOTE. THERE WAS NO CONSEQUENCE TO A PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 6MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16308675 ↗MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLES WERE OFF THE INSERTER. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15896314 ↗MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLES WERE OFF THE INSERTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE SPEED SHIFT 15X20X20 OFFSET 8MM IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15896229 ↗MalfunctionNov 28, 2022Break; Break
DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN SET INSPECTION AT DC ON (B)(6) 2022, THE BONE STAPLE WAS BROKEN INSIDE THE ORIGINAL PACKAGING. THE DEFECT WAS NOTICED THROUGH THE VIEWING WINDOW. THIS REPORT IS FOR A SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15874048 ↗MalfunctionOct 18, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT IT WAS DISCOVERED THREE SPEED SHIFT CCI IMPLANTS (SE-2020-10) THAT HAD THE WRONG DRILL GUIDE. THE DRILL GUIDE IN THE PACKAGING WAS FOR A 15-06 OFFSET OR PRODUCT CODE SE-1520-06. THE CORRECT DRILL GUIDE SHOULD BE FOR A SE-2020-10. THESE WERE FOUND IN IN INVENTORY BEFORE BEING DEPLOYED TO A CASE AND THERE WAS NO DIRECT IMPACT ON PATIENTS, SURGERY OR CUSTOMERS. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 20X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625121 ↗MalfunctionOct 18, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT IT WAS DISCOVERED THREE SPEED SHIFT CCI IMPLANTS (SE-2020-10) THAT HAD THE WRONG DRILL GUIDE. THE DRILL GUIDE IN THE PACKAGING WAS FOR A 15-06 OFFSET OR PRODUCT CODE SE-1520-06. THE CORRECT DRILL GUIDE SHOULD BE FOR A SE-2020-10. LOT NUMBER MSE210237. THESE WERE FOUND IN INVENTORY BEFORE BEING DEPLOYED TO A CASE AND THERE WAS NO DIRECT IMPACT ON PATIENTS, SURGERY OR CUSTOMERS. THIS REPORT INVOLVES ONE (1) SPEED SHIFT 20X20X20 OFFSET 10MM IMPLANT. THIS IS REPORT 3 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15625020 ↗MalfunctionOct 13, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT IT WAS DISCOVERED THREE SPEED SHIFT CCI IMPLANTS (SE-2020-10) THAT HAD THE WRONG DRILL GUIDE. THE DRILL GUIDE IN THE PACKAGING WAS FOR A 15-06 OFFSET OR PRODUCT CODE SE-1520-06. THE CORRECT DRILL GUIDE SHOULD BE FOR A SE-2020-10. LOT NUMBER MSE210237. THESE WERE FOUND IN OUR INVENTORY BEFORE BEING DEPLOYED TO A CASE AND THERE WAS NO DIRECT IMPACT ON PATIENTS, SURGERY OR CUSTOMERS. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15600926 ↗MalfunctionSep 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON (B)(6)2022 IN THE CHAMPAIGN IL SYNTHES TRAUMA TERRITORY (T362) WE FOUND 3 EACH THAT CONTAIN THE WRONG DRILL GUIDE. THEY CONTAIN A DRILL GUIDE FOR A 15-06 OFFSET STAPLE. THIS PRODUCT IS IN OUR POSSESSION. ALL THREE HAD THE SAME LOT NUMBER. NO SURGICAL DELAY AS IN REGARD TO THE EVENT. THERE WAS NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10 THIS IS REPORT 3 OF 3 FOR COMPLAINT PC-(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15418833 ↗MalfunctionSep 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON (B)(6) 2022, IN THE CHAMPAIGN IL SYNTHES TRAUMA TERRITORY (T362) WE FOUND 3 EACH THAT CONTAIN THE WRONG DRILL GUIDE. THEY CONTAIN A DRILL GUIDE FOR A 15-06 OFFSET STAPLE. THIS PRODUCT IS IN OUR POSSESSION. ALL THREE HAD THE SAME LOT NUMBER. NO SURGICAL DELAY AS IN REGARD TO THE EVENT. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15418827 ↗MalfunctionSep 14, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT ON (B)(6) 2022, IN THE (B)(6) SYNTHES TRAUMA TERRITORY (T362) WE FOUND 3 EACH THAT CONTAIN THE WRONG DRILL GUIDE. THEY CONTAIN A DRILL GUIDE FOR A 15-06 OFFSET STAPLE. THIS PRODUCT IS IN OUR POSSESSION. ALL THREE HAD THE SAME LOT NUMBER. NO SURGICAL DELAY AS IN REGARD TO THE EVENT. THERE WAS NO PATIENT OUTCOME/ CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15418820 ↗MalfunctionAug 25, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT THE PRODUCT CODE (B)(4), THE WRONG DRILL GUIDE WAS PACKAGED WITH THE PRODUCT. THE 15-06 DRILL GUIDE, TO BE USE WITH (B)(4), WAS PACKAGED WITH THE PRODUCT. THERE WERE NO SURGICAL DELAY . PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) SPEEDSHIFT COMP IMPL KIT 20X20X20 OFST10. THIS IS REPORT 1 OF 1 FOR (B)(4).COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15297549 ↗
Other Synthes GmbH products
All Synthes GmbH devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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