Synthes Small Electric Drive recall
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and…
Why was Synthes Small Electric Drive recalled?
The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/direction could cause bone/soft tissue, peripheral nerve, and /or vascular damage. Injuries may need surgical or medical intervention. Surgical delay and postoperative local infection are also potential risks.
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?
All lots of part number 05.001.175, lot numbers: 28, 40, 41, 42, 53, 105, 107, 111, 112, 113, 115.
- Product
- Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especially hand and…
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 12
- Distribution
- US Nationwide Distribution to Florida only
- Recall date
- January 14, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)