Recall Z-0716-2014— Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Biomet, Inc., initiated 2013-12-19, terminated 2015-07-07. It names 3 FDA 510(k) clearances: K082300, K072832, K072083. Product: Locking Cortical Screw 3.5mmX38mm REF 8161-35-038. Reason: 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw..
- Recalling firm
- Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-19
- Terminated
- 2015-07-07
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
3 on FDA's record- K082300 — ANATOMIC LOCKING PLATING SYSTEM
- K072832 — ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM
- K072083 — SMALL FRAGMENT LOCKING PLATING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Reason for recall
3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
Data sourced from openFDA. This site is unofficial and independent of the FDA.