| Date Initiated by Firm | May 29, 2019 |
|---|
| Create Date | August 14, 2019 |
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| Recall Status1 |
Terminated 3 on January 15, 2021 |
| Recall Number | Z-2278-2019 |
|---|
| Recall Event ID |
83372 |
| 510(K)Number | K143355 |
|---|
| Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
|
| Product | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System |
|---|
| Code Information |
Lot # 150115-09, 160427-01 and A162-02 |
Recalling Firm/
Manufacturer |
Pega Medical Inc.
1111 Chomedey (A-13) E
Laval Canada
|
| For Additional Information Contact | Enrique Garcia
450-688-5144 Ext. 242 |
|---|
Manufacturer Reason
for Recall | Handle could jam with the Driver due to the detachment of an internal Connector Ring. |
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FDA Determined
Cause 2 | Component design/selection |
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| Action | An e-mail was sent on May 25, 2019 to all their consignees with the following instructions.
Identify the device with the same catalogue number and lot number and return the device to Pega Medical Inc. as soon as possible to the address shown below using the FedEx Account number provided. Contact Enrique Garcia at (450) 688-5144 ext. 242 or egarcia@pegamedical.com for more information |
|---|
| Quantity in Commerce | 19 |
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| Distribution | CA, DE, FL, IL, NC, NE, NY and TN |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = HSB
|
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