POUCH/CARTON LABEL: ***REF 5023-138***9.5 x 25.5 x 0.4mm***QTY 1***MICRO SAGITTAL BLADE, FINE***STERILE***Rx Only***CONMED LINVATEC, CONMED LINVATEC 11211 CONCEPT BLVD LARGO, FL 33773-4908 USA***Made in USA*** To cut soft tissue or bone
This recall has been terminated (originally issued April 4, 2011).
- Recall Initiated
- November 30, 2010
- Posted
- April 4, 2011
- Terminated
- November 9, 2011
- Recall Number
- Z-1880-2011
- Quantity
- 415
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
On Nov 30, 2010 ConMed Linvatec, Largo, FL recalled their Micro Sagittal Blade, Fine Lot number 180209, Product Number 5023-138. Some units of Micro Sagittal Blade, Fine from Lot 180209 may have compromised seals in the sterile packaging.
Distribution
Worldwide Distribution - USA including CT, FL, GA, HI, IN, MO, MS, MT, NJ, NY, OH, PA, SC, and TX and the countries of Canada, and South Africa.
Lot / Code Info
Lot: 180209
Root Cause
Process control
Action Taken
Linvatec Corp. dba ConMed sent an Urgent Medical Device Recall Notification letter dated November 30, 2010, by FedEx, email, Fax, etc) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the reply form within 30 days of receipt. Immediately check their facility's inventory for the affected product and lot number. If they had any of the product with lot number 180209. Do Not Use. Segregate and return for credit. If the product was transferred to another facility, customers were to complete the REPLY FORM documenting the transfer of the product and fax the form to 727-319-5701. For questions regarding this recall call 727-319-5701 or 800-535-8536.