Modular Head Component recall
Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis…
Why was Modular Head Component recalled?
Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.
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 299340
- Product
- Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 18
- Distribution
- Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.
- Recall date
- May 9, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)