Recall Z-0286-2009 ยท FMQ Restraint, Protective
J T Posey Company
Posey Synthetic Leather and Biothane Waist and Wrist Restraints, Catalog Numbers: 2217SL and 2217B
| Date | Dec 2, 2008 (initiated Jul 25, 2008) |
| Status | Terminated |
| Reason | Failure to restrain: This recall was initiated after a complaint was received by the firm regarding a Posey 2217SL unit indicating that a patient was able to pull the rivet or washer through the synthetic leather allowing the patient to have freedom of arm movement. A second complaint was received indicating that a patient was able to tear the strap at the adjustment notch on a Posey 221 7SL unit |
| Root cause | Device Design |
| Action | On July 29, 2008 Posey sent a Recall Letter to all affected customers. The recall letters were sent by certified mail with return receipt signature. The recall letter instructed the customers not to distribute or use the affected products. Any existing inventory subject to this recall was requested to be returned to Posey Company. Also, if they were a distributor, they were asked to please additionally forward a copy of the recall notice and reply form to each of their customers to whom you have further distributed the subject product. A Recall Fax Back form was provided with the recall let |
| Quantity | 145 units |
| Distribution | Worldwide, USA, Australia, Canada, France & The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963413 | MULTIPLE LIMB HOLDERS J. T. Posey Co., Nov 14, 1996 |