| | Class 2 Device Recall PHYSICA HPS |  |
| Date Initiated by Firm | October 27, 2023 |
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| Date Posted | December 09, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0524-2024 |
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| Recall Event ID |
93329 |
| 510(K)Number | K213381 |
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| 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 |
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| Code Information |
Product Code: 6539.54.610
UDI-DI Code: 08033390212786
Lot/Sterilization Numbers:
2122621 / 2200149
2203871 / 2200167 |
| FEI Number |
3008021110
|
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 |
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Manufacturer Reason
for Recall | Due to incorrect product labeling |
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FDA Determined
Cause 2 | Labeling Change Control |
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| 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. |
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| Quantity in Commerce | 33 devices |
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| Distribution | U.S Distribution: AZ, CA, IL, LA, and NY
|
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = JWH
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