TSIRecalls & reported problems across all models
Tedan Surgical Innovations, L.L.C. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 5
We found 9 models of TSI by Tedan Surgical Innovations, L.L.C. in the FDA's device registry (GUDID). Together they are named in 12 adverse event reports in the FDA's MAUDE database, received between Jul 8, 2021 and Dec 19, 2025 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (6 reports).
5 FDA recall records name at least one of these models by its device identifier.
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
Reports received per month, all models
TSI 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.
- May 15, 2020Terminated
Lack of pouch seal. Product is labelled as sterile.
Z-2530-2020 · Root cause: Packaging change control · Recall details · FDA record ↗
- May 15, 2020Terminated
Lack of pouch seal. Product is labelled as sterile.
Z-2529-2020 · Root cause: Packaging change control · Recall details · FDA record ↗
- May 15, 2020Terminated
Lack of pouch seal. Product is labelled as sterile.
Z-2528-2020 · Root cause: Packaging change control · Recall details · FDA record ↗
- May 15, 2020Terminated
Lack of pouch seal. Product is labelled as sterile.
Z-2527-2020 · Root cause: Packaging change control · Recall details · FDA record ↗
- May 15, 2020Terminated
Lack of pouch seal. Product is labelled as sterile.
Z-2526-2020 · Root cause: Packaging change control · Recall details · FDA record ↗
Most reported TSI problems
Device problems
- Physical Resistance/Sticking6
- Material Fragmentation5
- Break4
- Crack4
- Detachment of Device or Device Component4
- Device Handling Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions12
TSI models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TSI DS-0012Orthopedic Manual Surgical Instrument1 recall0 reports
- TSI DS-0014Orthopedic Manual Surgical Instrument1 recall0 reports
- TSI DS-0022Orthopedic Manual Surgical Instrument1 recall0 reports
- TSI DS-0024Orthopedic Manual Surgical Instrument1 recall0 reports
- TSI DS-0026Orthopedic Manual Surgical Instrument1 recall0 reports
- TSI AL-0103Operating Room Accessories Table Tray6 reports
- TSI AL-0105Orthopedic Manual Surgical Instrument4 reports
- TSI AL-0106Retractor1 report
- TSI AL-0110Operating Room Accessories Table Tray1 report
Recent TSI adverse event reports
The 12 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 19, 2025Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem; Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem
DURING THE CASE, THE PIVOTING BLADE HOLDER TAB BROKE. TWO OF THE BLADE HOLDER TABS SNAPPED WHILE TIGHTENING THE RETRACTOR BLADE AND FLEW OUT OF THE STERILE FIELD. SUBSEQUENTLY, ANOTHER TWO BLADE HOLDER TABS SNAPPED DURING REST POSITION, EVEN WITHOUT ANY ONGOING TIGHTENING. THERE WAS NO PATIENT OR USER HARM THAT OCCURRED IN THIS INCIDENT. HOWEVER, THESE INCIDENTS POSE POTENTIAL SAFETY RISKS TO BOTH THE MEDICAL TEAM AND THE PATIENT PER THE HEALTHCARE PROFESSIONAL IN THE SURGICAL OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857388 ↗MalfunctionDec 19, 2025Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem; Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem
DURING THE CASE, THE PIVOTING BLADE HOLDER TAB BROKE. TWO OF THE BLADE HOLDER TABS SNAPPED WHILE TIGHTENING THE RETRACTOR BLADE AND FLEW OUT OF THE STERILE FIELD. SUBSEQUENTLY, ANOTHER TWO BLADE HOLDER TABS SNAPPED DURING REST POSITION, EVEN WITHOUT ANY ONGOING TIGHTENING. THERE WAS NO PATIENT OR USER HARM THAT OCCURRED IN THIS INCIDENT. HOWEVER, THESE INCIDENTS POSE POTENTIAL SAFETY RISKS TO BOTH THE MEDICAL TEAM AND THE PATIENT PER THE HEALTHCARE PROFESSIONAL IN THE SURGICAL OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857382 ↗MalfunctionDec 19, 2025Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem; Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem
DURING THE CASE, THE PIVOTING BLADE HOLDER TAB BROKE. TWO OF THE BLADE HOLDER TABS SNAPPED WHILE TIGHTENING THE RETRACTOR BLADE AND FLEW OUT OF THE STERILE FIELD. SUBSEQUENTLY, ANOTHER TWO BLADE HOLDER TABS SNAPPED DURING REST POSITION, EVEN WITHOUT ANY ONGOING TIGHTENING. THERE WAS NO PATIENT OR USER HARM THAT OCCURRED IN THIS INCIDENT. HOWEVER, THESE INCIDENTS POSE POTENTIAL SAFETY RISKS TO BOTH THE MEDICAL TEAM AND THE PATIENT PER THE HEALTHCARE PROFESSIONAL IN THE SURGICAL OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23857381 ↗MalfunctionDec 19, 2025Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem; Break; Crack; Material Fragmentation; Detachment of Device or Device Component; Device Handling Problem
DURING THE CASE, THE PIVOTING BLADE HOLDER TAB BROKE. TWO OF THE BLADE HOLDER TABS SNAPPED WHILE TIGHTENING THE RETRACTOR BLADE AND FLEW OUT OF THE STERILE FIELD. SUBSEQUENTLY, ANOTHER TWO BLADE HOLDER TABS SNAPPED DURING REST POSITION, EVEN WITHOUT ANY ONGOING TIGHTENING. THERE WAS NO PATIENT OR USER HARM THAT OCCURRED IN THIS INCIDENT. HOWEVER, THESE INCIDENTS POSE POTENTIAL SAFETY RISKS TO BOTH THE MEDICAL TEAM AND THE PATIENT PER THE HEALTHCARE PROFESSIONAL IN THE SURGICAL OPERATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23855791 ↗MalfunctionJan 3, 2025
PHANTOM RETRACTOR HANDLE BROKE DURING USE. METAL PORTION BROKEN AT TIP. ALL BROKEN PARTS RETRIEVED, AND PATIENT REMAINED SAFE AND UNHARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21066082 ↗MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON 18 MARCH 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 1 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19326157 ↗MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:(B)(4), P/N: (B)(6), LOT:1222) & (QTY:(B)(4), P/N: (B)(6), LOT:0423). THIS REPORT IS 5 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED. ON 30 MAY 2024 THE EVALUATION WAS COMPLETED AND AS A RESULT THIS SUPPLEMENTAL REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19326064 ↗MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 4 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19326061 ↗MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL (B)(6) RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2024 THE (B)(6) RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:(B)(4), P/N: (B)(6), LOT:1222) & (QTY:(B)(4), P/N: (B)(6), LOT:0423). THIS REPORT IS 3 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED. ON 30 MAY 2024 THE EVALUATION WAS COMPLETED AND AS A RESULT THIS SUPPLEMENTAL REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19326054 ↗MalfunctionMay 15, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON 17 APRIL 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS 2 OUT OF 5 FOR LOT 0423. THIS EVENT WAS ORIGINALLY REPORTED UNDER 3012120772-2024-00009. THIS REPORT WAS FILED TO DOCUMENT THE DIFFERENT LOT NUMBERS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19326046 ↗MalfunctionApr 12, 2024Physical Resistance/Sticking; Physical Resistance/Sticking
ON 18 MARCH 2024, SEASPINE WAS MADE AWARE OF AN INTRA-OPERATIVE MALFUNCTION INVOLVING THE ALIF RETRACTOR SYSTEM. THE CASE OCCURRED ON (B)(6) 2024. IT WAS REPORTED THAT SEVERAL AL-0103 RING CLAMPS FROZE MID-CASE WHICH MADE CHANGING THE BLADES DIFFICULT. THIS MALFUNCTION CAUSED A SURGICAL DELAY OF APPROXIMATELY 45-60 MINUTES. THE CASE WAS COMPLETED AFTER THE PROPER RETRACTION WAS ACHIEVED. NO PATIENT INJURY WAS REPORTED. ON (B)(6) 2024 THE AL-0103 RING CLAMPS WERE RECEIVED FOR EVALUATION. THE RETURNED PARTS ARE AS FOLLOW: (QTY:1, P/N: AL-0103, LOT:1222) & (QTY:5, P/N: AL-0103, LOT:0423). THIS REPORT IS FOR LOT 1222.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19102136 ↗MalfunctionJul 8, 2021Material Fragmentation; Material Fragmentation
IT WAS REPORTED TO THE DISTRIBUTOR, THAT WHILE THE PROCEDURE WAS TAKING PLACE, A SCREW BROKE INTO 2 WHILE THE ARM WAS INSTALLED PROPERLY. ONE OF THE TWO PARTS "PROJECTED" AND HIT AN OR PERSONNEL IN THE HEAD AND FELL (TRANSLATED FROM FRENCH).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12137439 ↗
Other Tedan Surgical Innovations, L.L.C. products
All Tedan Surgical Innovations, L.L.C. 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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