Recall Z-1238-2024— Synthes (USA) Products LLC

Name: FDA recall Z-1238-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-24

Class II · Ongoing

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2024-01-24. It names one FDA 510(k) clearance: K141385. Product: RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S. Reason: Products not sterilized, sterility cannot be confirmed.

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Ongoing
Initiated: 2024-01-24
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K141385 — DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)Depuy Synthes Companies of Johnson & Johnson·cleared 2015-03-27

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

RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S

Reason for recall

Products not sterilized, sterility cannot be confirmed

Data sourced from openFDA. This site is unofficial and independent of the FDA.