LACTOSORB SYSTEM 2.0MM ADJUSTABLE SELF-DRILLING TAP, REF: 915-2075, NON-STERILE PRODUCT, BIOMET MICROFIXATION,K INC. 1520 TRA DEPORT DRIVE JACKSONVILLE, FL 32218 USA. www.biometmicrofixation.com. Lacto Sorb Self Drilling Taps are used to drill and tap holes. They are self drilling so they do not require a hole to be drilled prior to use. They are used along with the Lacto SorbBulbs Handles or Power Drivers to advance the Tap into the bone.
This recall has been terminated (originally issued January 4, 2010).
- Company
- Biomet Microfixation, Inc.
- Recall Initiated
- September 15, 2009
- Posted
- January 4, 2010
- Terminated
- January 23, 2010
- Recall Number
- Z-0489-2010
- Quantity
- 15 pieces
- Firm Location
- Jacksonville, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.
Distribution
USA - FL, MO, and KS; Foreign: Brazil and China.
Lot / Code Info
Lot Number: 064350
Root Cause
Component change control
Action Taken
Biomet Microfixation notified consignees of the recalled product beginning September 2009 via telephone and e-mail correspondence. Users were asked to return the affected product to the firm. For further information, contact Biomet Microfixation at 1-904-741-9468.