Data Foundry

Medical device recalls 2014

Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM… — Class II medical device recall Z-0583-2014

Terminated recall by Stryker Howmedica Osteonics Corp., reported 2014-01-01, distributed nationwide. Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impact

Recall numberZ-0583-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Howmedica Osteonics Corp., Mahwah, NJ, United States
Recall initiated2013-09-30
Classified2013-12-26
Reported by FDA2014-01-01
Terminated2016-10-19
DistributedNationwide (US)
Quantity1,024 units
Reason classespackaging, device malfunction
Model numbers1235-0-014

Product

Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

Reason for recall

Stryker has received complaints associated with cracks and/or fracture of the Ball Impactor Tip and Rim Impactor Tip Instruments.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0583-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.