FDA (Devices) recall action 66909
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.
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.
Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.
Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.