Overview of recall records associated with Synthes (USA) Products LLC, including dates, categories and classifications where available.
Classification mix: Class II: 57, Class III: 15.
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"
May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can…
Modified outside of approved manufacturing process
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread…
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
There is a potential for microspores to form on the hollow handle of the Sciatic Nerve Retractor. The pores may increase in size, allowing fluid to enter the hollow handle.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
This page summarizes recall records in which the official source identifies Synthes (USA) Products LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
