Zimmer Recalls Multipolar Bipolar Cup Liners Due to Assembly Error
Zimmer, Inc. is removing 195 Multipolar Bipolar Cup Liners because the split poly ring was incorrectly assembled. The recall covers units distributed in the US and several international countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a manufacturing defect (incorrect assembly) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Zimmer, Inc. is initiating a removal of the Multipolar Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled. The product is a medical device used as the articulation surface for the femoral head in a bipolar cup.
The recall affects 195 units. Distribution was worldwide, including the United States (specifically AK, CA, IL, FL, HI, MI, MO, NC, NJ, NY, OH, PA, and TX) and the countries of Germany, Brazil, Canada, Japan, Taiwan, Thailand, India, and Korea. The affected lot numbers are 61261192, 61261194, and 61296091.
Healthcare providers and patients should check their inventory or surgical records for these specific item and lot numbers. If the product is identified, it should be removed from use and returned to Zimmer, Inc. according to their instructions.
The recalled product
- Product
- Multipolar¿ Bipolar Cup Liner 22 mm LD.; Item 00-5001-040-22 Product Usage: The liner snaps into the Multipolar¿ Bipolar Cup and serves as the articulation surface for the femoral head. The split poly locking ring helps contain the head within the liner and also provides a…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 195
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Item 00-5001-040- 22
- Lot 61261192
- 61261194
- 61296091
Distribution
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