SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm recall
SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR…
Why was SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm recalled?
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
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: 14AA234, 14AA235, 14AA233
- Product
- SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR…
- Recalling firm
- Limacorporate S.p.A
- Quantity
- 110 units
- Distribution
- US Distribution to the states of: OH, TX, NC, NY, CA, FL, KS, AL, MI, MT, CO, MO, NV, WA, MN and LA., and Internationally to Australia.
- Recall date
- September 9, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)