Lactosorb Trauma Plating System, part numbers: 915-2100, 915-2423, 915-2113, 915-2810, 915-2418, 915-2105, 915-2832 and
FDA device recall Z-1872-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Biomet Microfixation, Inc.
- Reason for recall
- The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).
- Action taken
- On 3/19/08 the firm issued an Urgent Medical Device Recall Notice to its consignees by certified letters with return receipt. All returned products will be held in quarantine until final disposition is determined. If you have any questions contact Rachel Osbeck at 1-800-874-7711 or (904) 741-4400 ext 448.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 117
- Distribution
- Class II Recall - Worldwide Distribution --- USA including states of NC, MI, TX, GA, HI, OK, IN and CA, and countries of Denmark, Germany, Mexico, Italy, Brazil, Japan, Canada, South Africa, China and
- Date initiated
- 2008-03-19
- Date posted
- 2008-09-16
- Date terminated
- 2009-09-11
- Location
- Jacksonville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LACTOSORB PANELS AND FASTENERS (K980927) | Biomet, Inc. | 1998-06-05 |
| LACTOSORB TRAUMA PLATING SYSTEM (K955729) | Poly-Medics,Inc. | 1996-02-14 |