00780302801 MIS 12/14 Slotted Femoral Head Provisional recall
00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14…
Why was 00780302801 MIS 12/14 Slotted Femoral Head Provisional recalled?
Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp
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 including lot 78939000 (1/7/2002) to present
- Product
- 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS 12/14 Slotted Femoral Head Provisional +0X28 00780302803 MIS 12/14…
- Recalling firm
- Zimmer, Inc.
- Quantity
- 231,641 all lots, all sizes
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
- Recall date
- October 10, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)