REF 5100-088 recall
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order…
Why was REF 5100-088 recalled?
It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical ma
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
10933, 11433, 11483, 20553, 30163, 31553, 40713, 40833, 41113, 50463, 60133, 60423, 90383, 110093, 110193, 1030133, 1030403, 1040413, 2010013, 2010123, 96090403, 96091343, 97020193, 97030013, 97030543, 97050243, 97060163, 97080033, 98010083, 98020703, 98030103, 98040213, 98060023, 98061033, 98070603, 98090023, 98090473, 98090503, 98101143, 98110323, 99010433, 99030253, 99050033, 99050383, 99060163, 99060423, 99061063, 99061283, 99070453, 99071293, 99080243, 99080483, 99090913, 99101273, 221303733, 326102033, 434909453, 500800103, 504900233, 631112793, 631414853, 700314923, 723606673, 725315933, 735502183, 813304543, and 921700523 ,
- Product
- REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order…
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Quantity
- 67
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Australia, Canada, France, Germany, Italy, Japan, Spain, Switzerland, and United Kingdom.
- Recall date
- November 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)