Modular Stem cylindrical, Tilastan, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
FDA Recall Z-1372-2025 · Posted 2025-03-17
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Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeJWH
Date Initiated2025-02-14
Product Quantity37 units
Reason for Recall
A problem was discovered during the scanning process of the outer carton label because of an incorrect GTIN on the label, which is a GTIN for a different product.
Firm Action
On February 21, 2025 URGENT: MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken by the Customer/User:
Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address:
LinkBio Corporation
69 King St
Dover, NJ 07801
Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Root Cause
Labeling Change Control
Distribution Pattern
Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IN, KS, MO, NJ, NV, OH TX, VA, WI and the countries of Germany, Italy, Spain, Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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