PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI K
FDA device recall Z-0495-2015 · posted 2014-12-16 · Terminated
Recall details
- Recalling firm
- Zimmer CAS
- Reason for recall
- Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
- Action taken
- The firm, Zimmer CAS, sent an "URGENT: MEDICAL DEVICE NOTIFICATION" dated November 3, 2014 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to read this notice and be familiar with its contents; complete and return the attachment 1 CERTIFICATE OF ACKNOWLEDGEMENT form via fax to Zimmer Inc. at (574) 372-4265 or scan and email to corporatequality.postmarket@zimmer.com; and maintain a copy of the completed attachment 1 for your files. If you have questions concerning this notice, please call 514-861-4074 ext 292 or email: jean-sebastien.merette@zimmercas.com
- Root cause
- Software design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 15
- Distribution
- US Distribution in states of: AZ, CO, IL, OR, and WA.
- Date initiated
- 2014-11-03
- Date posted
- 2014-12-16
- Date terminated
- 2015-02-13
- Location
- Montreal, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CAS PSI KNEE SYSTEM (K131409) | Orthosoft, Inc. | 2013-09-13 |