Zimmer Biomet Recalls Lactosorb RapidFlap Bone Plates Due to Threading Defect
Zimmer Biomet is recalling Lactosorb RapidFlap bone plates because excessive chamfering on the threads prevents proper engagement with the post component.
What this means for you
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 is classified as FDA Class II, and the defect involves a structural failure of a medical device used in pediatric surgery, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling Lactosorb RapidFlap bone plates, Model No. 915-0020, which are part of the RapidFlap LS Cranial Fixation System. These devices are indicated for use in pediatric craniotomy flap fixation. The recall involves 13,175 units distributed worldwide, including in the United States and several international countries.
The recall was initiated because the recalling firm confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This defect results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.
The affected lots are listed in the agency's recall record. Consumers and healthcare providers should contact Zimmer Biomet for instructions on how to handle the recalled devices.
The recalled product
- Product
- Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 13,175
Distribution
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