—#118471

Product

Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.

FDA product code: HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K110791
Affected lot / code info: Item 00-4301-012-17; lot 62283991

Why it was recalled

The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer sent an URGENT MEDICAL DEVICE RECALL notification dated June 11, 2013, to all consignees via email and courier describing the affected device and problem and the risks associated with using the affected device. The notifications provided instructions for returning the affected device to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. Any questions or concerns concerning the recall, please call the customer call center at 1-877-946-2761. Customers may report adverse events or quality problems experienced with the use of these products to Zimmer by email at zimmer.per@zimmer.com. For questions regarding this recall call 800-613-6131.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Nationwide Distribution including IL and MO.

Timeline

Recall initiated: 2013-06-11
Posted by FDA: 2013-07-10
Terminated: 2014-01-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.