Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors
Zimmer Biomet is recalling 18 modular hip head components because two lots of different sizes were potentially commingled. This may lead to the use of an incorrect sized head.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of dislocation, which constitutes a significant injury report per the severity rubric.
Plain-English summary
Zimmer Biomet, Inc. is recalling 18 units of the Modular Head Component, Biomet Hip System (Item No. 11-363661). The recall involves lot 299340. The device is a metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis used in total hip arthroplasty.
The recall was initiated because two lots of different sized modular heads were potentially commingled. The use of an incorrect sized head poses risks of delay in surgery and dislocation.
The affected devices were distributed nationwide in the United States in the states of AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA, as well as in Canada, Costa Rica, and Chile. Healthcare providers should stop using the affected components and contact Zimmer Biomet for instructions on how to proceed.
The recalled product
- Product
- Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and correspond
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 18
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 (1)
- lot 299340
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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Same hazard · dislocation
See all →- HighZimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors
FDA (Devices) · 2018-05-09