Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

FDA Recall Z-1526-2018 · Posted None

Recalling FirmStryker GmbH
Recall StatusTerminated
Product CodeKTT
Date Initiated2018-03-12
Date Terminated2020-05-21
Product Quantity18

Reason for Recall

The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling

Firm Action

Stryker sent an Urgent Product Recall letter dated March 12, 2018, to all affected customers. . Product will be returned to the manufacturer for disposition. Non-responding consignees will be attempted to be contacted a minimum of three times in total. Returned product will be quarantined and returned to the manufacturer. Product will be returned to the manufacturer for disposition. For further questions, please call (201) 831-5272.

Root Cause

Labeling mix-ups

Distribution Pattern

USA (nationwide) Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113327HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEMStryker Corp. · 2012-03-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑