Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in an inner foil pouch inside outer
FDA device recall Z-2623-2010 · posted 2010-09-29 · Terminated
Recall details
- Recalling firm
- LifeCell Corporation
- Reason for recall
- Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.
- Action taken
- LifeCell issued Recall Notice letters dated July 12, 2010 to customers, identifying the affected product, the labeling issue, and actions to be taken by the customer. Two versions of the recall notification were sent, one for implanted units and one for those not yet implanted. Both letters stated that the mislabeling has no impact of the safety or effectiveness of the medical device. Replacement units were offered for all affected units. Those with unused units were to contact LifeCell Customer Solutions for return and replacement of the unit at 1-866-423-2433. Those with implanted units may contact LifeCell Customer Solutions at 1-866-423-2433 with any additional questions or concerns.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FTM
- Quantity affected
- 32 units
- Distribution
- Nationwide Distribution: USA, including the states of AZ, DC, FL, GA, ID, IL, KY, LA, MO, NC, OH, OK, OR, TX, WA, and WI.
- Date initiated
- 2010-07-12
- Date posted
- 2010-09-29
- Date terminated
- 2010-10-01
- Location
- Somerville, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LRTM SURGICAL MESH (K070560) | Lifecell Corp. | 2007-06-11 |