Synthes Oracle Spacer System Slap Hammer recall
Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with…
Why was Synthes Oracle Spacer System Slap Hammer recalled?
This recall is being initiated in response to complaints received where it was reported that the proximal end of the Slap Hammer broke during use.
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?
Part number 03.809.690, Lot Number 6723847
- Product
- Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 The Oracle Spacer is indicated for use in patients with…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 27
- Distribution
- Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
- Recall date
- October 2, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)