FDA Device Recall Z-0041-2018: Recall Record

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0041-2018.

Recall Res Number

Z-0041-2018

Recalling Firm / Manufacturer

N/A

FEI Number

1000116912

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2017-09-15

Date Posted

N/A

Date Terminated

2023-08-29

Product Code

JWH

Event Number

78193

Product Quantity

48 units

Product Description EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is posterior stabilized and is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

Reason for Recall It was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

Action Details The firm initiated the recall by email on 09/05/2017. The letter identified the affected product, problem and actions to be taken. The consignee was directed to notify anyone to whom the product was transferred and to return any in-stock product.

Distribution Pattern US Nationwide Distribution

Code Information / Serial Numbers Lot Number 287U1004

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Medical Device Recall: Z-0041-2018

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer