—#90163

Product

Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K091508
Affected lot / code info: 61255960, 61286739, 61293344, 61297228, 61301146, 61303916, 61321619, 61341496, 61341497, 61351886, 61361912, 61361919, 61369266, 61371666, 61371667, 61387139, 61396637 and 61413131.

Why it was recalled

The firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.

Root cause (FDA determination)

Device Design

Action the firm took

The firm sent Urgent: Device Removal letters dated 3/15/2010. The letter identified the affected product, described the issue, discussed the clinical implications, and provided a list of required actions. The consignees were instructed to perform an inventory of the recalled product and report the amount on hand to Zimmer by completing the Inventory Return Certification Form. After Zimmer received the report, they would send out new product to the consignee. After new product was received the consignees were instructed to return the recalled product to Zimmer. The firm expects to have all product replaced by 4/30/2010. If there are any questions or additional info needed, consignees should contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.

Timeline

Recall initiated: 2010-03-19
Posted by FDA: 2010-10-15
Terminated: 2011-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90163. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.