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Biomet, Inc. Recall 89544

Description: Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633

Biomet, Inc. Recall 89544 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0676-2022
Event ID89544
Event DescriptionComprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.
Quantity9 units
Recall ReasonThe products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.
Device Classification20220302
Device Code InfoLot Number: 994800 UDI:(01)00880304462632(17)290816(10)994800
Center Classification Date20220224
Recall Initiation Date20220107
Recalling FirmBiomet, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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