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U.S. Department of Health and Human Services

Class 2 Device Recall REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP

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 Class 2 Device Recall REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSPsee related information
Date Initiated by FirmAugust 22, 2023
Date PostedOctober 12, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0098-2024
Recall Event ID 93080
510(K)NumberK041066 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
ProductREVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Code Information UDI-DI: 00888912024570, Lot: 835C2074, EXP: 2029-03-9
Recalling Firm/
Manufacturer		 Encore Medical, LP
9800 Metric Blvd
Austin TX 78758-5445
For Additional Information Contact
512-834-6200
Manufacturer Reason
for Recall		Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
FDA Determined
Cause 2		Mixed-up of materials/components
ActionOn 8/22/23, recall notices were emailed to agents and registration holders who were asked to do the following: Contact Customer Service at 1-800-456-8696 to assist with return and replacement. This notice needs to be passed on to all those within your organization or to any organization where the potentially affected product has been transferred. Complete and return the acknowledgement and response form. If you have questions, please email productsafety@enovis.com
Quantity in Commerce70
DistributionUS: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MX
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PHX
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