FDA (Devices) recall action 79157
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Synthes (USA) Products LLC is recalling 1,144 sterile 2.5 mm Reaming Rods due to potential gaps in the package seal that may compromise sterility.
Synthes (USA) Products LLC is recalling sterile Light Clips for the Oracle Retractor because potential gaps in the package seal may compromise sterility. The product is used during orthopedic surgery.
Synthes (USA) Products LLC is recalling 63 units of 2.5 mm Titanium Calibrated Reaming Rods because potential gaps in the package seal may have compromised product sterility.
Synthes (USA) Products LLC is recalling 960 sterile 3.0 mm Reaming Rods because package seal defects may compromise sterility.
Synthes (USA) Products LLC is recalling 216 units of 2.5 mm Reaming Rods because package seal defects may have compromised sterility.
Synthes (USA) Products LLC is recalling 21 sterile 2.5 mm Guide Rods due to potential package seal defects that may compromise sterility.
Synthes (USA) Products LLC is recalling 2.5 mm Reaming Rods because package seal defects may have compromised sterility. The devices are used in orthopedic surgery.