Large Combination Clamp/Large External Fixation System recall
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to…
Why was Large Combination Clamp/Large External Fixation System recalled?
The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
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?
Lot Numbers 6602070, 6582333, 6581191, and 6581193
- Product
- Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to…
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 136
- Distribution
- USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
- Recall date
- March 20, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)