Waldemar Link GmbH & Co. KG (Mfg Site) recalls Plastic Trial Head Brown
Reason for recall
Inconsistent size terminology and color coding used on labeling
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- Plastic Trial Head Brown, 7 mm neck length. Item Number:175-928/15UDI-DI 04026575150700.2 affected lotsC126168C424053
What the firm is doing
Waldemar Link GmbH & Co. notified consignees of the recall via email on about 07/15/2025. Consignees were instructed to respond using the Distributor Reply form and arrange for the return of all affected product on hand.
DistributionShow detailsHide
Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IN, KS, LA, NJ and the countries of Germany, Argentina, Belgium, Switzerland, Cyprus, Algeria, Finland, Hungary, Mexico, Netherlands, Peru, Slovenia, and Uruguay.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2289-2025
- FDA device classification · JDGOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3360The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Waldemar Link GmbH & Co. KG (Mfg Site)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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