8 MM DISPOSABLE CORING TREPHINE STAGGERED TEETH WITH PROTECTION SLEEVE, REF 900788, Sterile, BIOMET Sports Medicine, War
FDA device recall Z-2605-2010 · posted 2010-09-28 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The affected instruments are discolored and/or have a sticky residue on the end.
- Action taken
- The firm sent out "Urgent Medical Device Recall" notices dated 7/1/2010. Letters were sent to distributors, customers and OR managers. The letters stated that the devices should be located, quarantined and shipped back to the recalling firm. On 7/15/2010, the firm added one lot of one additional product to the recall (product 900788 lot 780470). The firm sent letters to physicians that had used that lot of product. Questions relating to this recall should be directed to 574-371-3755.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 40
- Distribution
- US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
- Date initiated
- 2010-07-01
- Date posted
- 2010-09-28
- Date terminated
- 2012-08-20
- Location
- Warsaw, IN
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