Recall Z-1040-2014 ยท HWC Screw, Fixation, Bone
Zimmer, Inc.
PERI SCR. 3.5MM X 10MM PERI SCR. 3.5MM X 12MM PERI SCR. 3.5MM X 14MM PERI SCR 3.5MM X 44MM STE PERI SCR. 3.5MM X 65MM PERI. SCR 4.0MM X24MM PERI. SCR 4.0MM X40MM PERI SCR. 4.0MMX14MM FULL PERI SCR. 4.0MMX32MM FULL PERI SCR. 4.0MMX38MM FULL 3.5MM CORT SCR X 10MM 3.5MM CORT SCR X 12MM 3.5MM CORT SCR X 14MM 3.5MM CORT SCR X 16MM 3.5MM CORT SCR X 18MM 3.5MM CORT
| Date | Feb 20, 2014 (initiated Oct 11, 2013) |
| Status | Terminated |
| Reason | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These p |
| Root cause | Packaging |
| Action | Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals. |
| Quantity | 7,044,680 total |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112885 | ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY Zimmer, Inc., Dec 19, 2011 |