FDA Medical Device Recalls (openFDA)
Linvatec Corp. dba ConMed Linvatec: 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
- Recall number
- Z-1880-2011
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Product
- 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
- Status
- Terminated
- Initiated
- 2010-11-30
- Posted
- 2011-04-04
- Terminated
- 2011-11-09
- Reason
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 415
- 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, serial or model codes
- Lot: 180209
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWE
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06