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U.S. Department of Health and Human Services

Class 2 Device Recall PHYSICA HPS

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  Class 2 Device Recall PHYSICA HPS see related information
Date Initiated by Firm October 27, 2023
Date Posted December 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-0524-2024
Recall Event ID 93329
510(K)Number K213381  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Code Information Product Code: 6539.54.610 UDI-DI Code: 08033390212786 Lot/Sterilization Numbers: 2122621 / 2200149 2203871 / 2200167
Recalling Firm/
Manufacturer		 Limacorporate S.p.A
Via Nazionale 52
Di San Daniele
San Daniele Del Friuli Italy
For Additional Information Contact Roberto Gabetta
+390432945511
Manufacturer Reason
for Recall		 Due to incorrect product labeling
FDA Determined
Cause 2		 Labeling Change Control
Action On 10/27/2023, the firm sent via email an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that the firm was made aware of a mistake on the label of the HPS tibial liner #6H. 10mm. Customers are instructed to: Check their stock to locate and quarantine the affected devices. Devices must be sent back to the Lima local reference within 15 days together with a hard copy of the attached Acknowledgement and Receipt Form at the following address: Lima U.S.A., Inc. | 2001 NE Green Oaks Blvd. Ste.100 | Arlington, Texas 76006 | USA For questions or further assistance, email medicalcomplaints@limacorporate.com.
Quantity in Commerce 33 devices
Distribution U.S Distribution: AZ, CA, IL, LA, and NY
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JWH and Original Applicant = LimaCorporate S.p.A
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