Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer
FDA device recall Z-0060-2011 · posted 2010-10-14 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.
- Action taken
- The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 24
- Distribution
- Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.
- Date initiated
- 2010-08-18
- Date posted
- 2010-10-14
- Date terminated
- 2011-02-07
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM (K021891) | Zimmer, Inc. | 2002-09-05 |