Recall Z-1360-2015— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2015-03-10, terminated 2015-11-06. It names one FDA 510(k) clearance: K113369. Product: Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.. Reason: Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-10
- Terminated
- 2015-11-06
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Brand Name: Persona¿ Anterior Referencing Sizer with Locking Boom The Persona Anterior Referencing Sizer is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. The Persona Surgical Technique (97-5026-001-00, Rev. 9) states that the sizer helps ensure that the desired external rotation is attained and provides a size for the femoral component.
Reason for recall
Zimmer, Inc is voluntarily recalling 22 lots of Persona¿ Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.
Data sourced from openFDA. This site is unofficial and independent of the FDA.