GAMMARecalls & reported problems across all models
Stryker GmbH · 249 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one GAMMA model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,715
- Deaths reported
- 4
- Injuries reported
- 1,209
- Recalls
- 1
We found 249 models of GAMMA by Stryker GmbH in the FDA's device registry (GUDID). Together they are named in 1,715 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2015 and Sep 30, 2026 — classified as 4 deaths, 1,209 injuries, 502 malfunctions.
The most frequently reported specific device problem is “Fracture” (519 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
Reports received per month, all models
GAMMA 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 28, 2025Open, Classified
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Z-1914-2025 · Root cause: Process design · Recall details · FDA record ↗
Most reported GAMMA problems
Device problems
- Fracture519
- Break364
- Adverse Event Without Identified Device or Use Problem239
- Appropriate Device Problem Term/Code Not Available234
- Failure to Align119
- Insufficient Device Problem Information104
- Positioning Failure65
- Migration53
Patient problems
- No Clinical Signs, Symptoms or Conditions347
- Failure of Implant287
- Death198
- No Code Available175
- No Known Impact Or Consequence To Patient145
- Nonunion/Delayed-union Bone Fracture131
- Insufficient Information116
- Implant Pain101
GAMMA models
249 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- GAMMA 3125-1180SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES249 reports
- GAMMA 1320-0111ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES99 reports
- GAMMA 3060-0095SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES66 reports
- GAMMA 1320-0200ORTHOPEDIC MANUAL SURGICAL INSTRUMENT65 reports
- GAMMA 3060-0100SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES59 reports
- GAMMA 8425-0320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall3 reports
- GAMMA 3060-0105SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES43 reports
- GAMMA 3060-0090SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES36 reports
- GAMMA 3125-1200SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES34 reports
- GAMMA 1320-0233ORTHOPEDIC MANUAL SURGICAL INSTRUMENT29 reports
- GAMMA 3060-0110SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES27 reports
- GAMMA 1420-0100ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 death25 reports
- GAMMA 3130-1180SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES24 reports
- GAMMA 1320-0090ORTHOPEDIC MANUAL SURGICAL INSTRUMENT23 reports
- GAMMA 3325-0380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES21 reports
- GAMMA 8125-0170SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES21 reports
- GAMMA 8166-0090SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES20 reports
- GAMMA 1320-3042ORTHOPEDIC MANUAL SURGICAL INSTRUMENT19 reports
- GAMMA 1420-2100ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES19 reports
- GAMMA 3125-0170SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES18 reports
- GAMMA 1320-0125ORTHOPEDIC MANUAL SURGICAL INSTRUMENT18 reports
- GAMMA 3060-0085SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES17 reports
- GAMMA 3525-1360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES17 reports
- GAMMA 1320-0310ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES16 reports
- GAMMA 3425-1380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES15 reports
- GAMMA 8166-0085SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES15 reports
- GAMMA 8125-1170SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES14 reports
- GAMMA 3003-0822SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- GAMMA 3325-0360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- GAMMA 3525-1400SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES13 reports
- GAMMA 3225-0360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- GAMMA 3425-1360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES12 reports
- GAMMA 3225-0320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- GAMMA 3225-0380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- GAMMA 8325-0240SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES11 reports
- GAMMA 3060-0080SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- GAMMA 3066-0090SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- GAMMA 3525-1380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- GAMMA 1420-0110ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES10 reports
- GAMMA 3060-0115SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- GAMMA 3130-0170SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- GAMMA 3066-0095SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- GAMMA 3525-1340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- GAMMA 8166-0080SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- GAMMA 8225-0240SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES9 reports
- GAMMA 3425-0260SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- GAMMA 3225-0340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- GAMMA 3425-1340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- GAMMA 8160-0090SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- GAMMA 8160-0085SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- GAMMA 3130-1200SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 3525-0260SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 3525-0360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 3525-0380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 3325-0340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 3325-0400SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 8525-0340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 8160-0095SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 8166-0100SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- GAMMA 1320-3042SORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- GAMMA 1320-3010ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- GAMMA 1320-0191ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6 reports
- GAMMA 8525-0360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- GAMMA 8425-1420SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- GAMMA 8125-2170SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 death6 reports
- GAMMA 8004-0005SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- GAMMA 8160-0100SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES6 reports
- GAMMA 3120-1180SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3425-0320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3425-0360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3525-0320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 1320-0330ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3066-0080SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3066-0085SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3225-0400SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3525-1320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3525-1420SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 8525-0380SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 8425-0360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 8004-0000SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 8160-0105SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- GAMMA 3130-2170SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3420-0280SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3425-0300SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3525-0300SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 1320-0070ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- GAMMA 3525-3360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3525-3400SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3225-0420SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 1320-1118ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- GAMMA 1320-1010ORTHOPEDIC MANUAL SURGICAL INSTRUMENT4 reports
- GAMMA 3425-1280SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3425-1320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3430-1360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 8425-0340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- GAMMA 3060-0070SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- GAMMA 3060-0120SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- GAMMA 3420-0320SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- GAMMA 3425-0280SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- GAMMA 3425-0340SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
Recent GAMMA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953389 ↗MalfunctionSep 30, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952919 ↗MalfunctionSep 30, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952918 ↗InjurySep 29, 2026Fracture
Patient problems: Fall; Limb Fracture
MAUDE report 50934363 ↗MalfunctionSep 29, 2026Fracture
As reported: "The patient visited the doctor, and X-ray imaging confirmed a broken GAMMA3 Nail."
Patient problems: Insufficient Information
MAUDE report 50934328 ↗MalfunctionSep 28, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917223 ↗MalfunctionSep 28, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917221 ↗MalfunctionSep 28, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917219 ↗MalfunctionSep 23, 2026Fracture
As reported: "Fracture, Gamma3 clamping system."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870959 ↗InjurySep 21, 2026Malposition of Device
As reported: "During the insertion of the U-blade via impaction, the lag screw perforated the femoral head. The lag screw was removed, the void was filled with artificial bone, and the lag screw was reinserted."
Patient problems: Perforation
MAUDE report 50841188 ↗MalfunctionSep 21, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841125 ↗MalfunctionSep 16, 2026Failure to Align
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793055 ↗InjurySep 14, 2026Fracture
A broken Gamma3 nail as reported. The patient required revision surgery.
Patient problems: Insufficient Information
MAUDE report 50756193 ↗InjurySep 1, 2026Failure to Align
As reported: "On the (b)(6)2026 a G4 Intermediate Nail has been used at (b)(6). The distal locking screw through the Gamma4 targeted jig missed the nail. This was believed to be corrected at the time by re-attaching the jig and checking on Xray. However, at a follow up Xray the screw has appeared to miss posteriorly compared to it previously missing anteriorly. This resulted in the patient coming back to theatre on the (b)(6)2026 to have another distal screw inserted through the nail."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550090 ↗InjurySep 1, 2026Positioning Failure
As reported: "On the (b)(6) 2026 a G4 Intermediate Nail has been used at (b)(6) Hospital. The distal locking screw through the Gamma4 targeted jig missed the nail. This was believed to be corrected at the time by re-attaching the jig and checking on Xray. However, at a follow up Xray the screw has appeared to miss posteriorly compared to it previously missing anteriorly. This resulted in the patient coming back to theatre on the (b)(6) 2026 to have another distal screw inserted through the nail."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50549684 ↗
Other Stryker GmbH products
All Stryker 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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