Battery, Replacement, Rechargeable
General, Plastic Surgery · 21 CFR 878.4820
Recent MDR events
4,301 adverse event reports on file
- UNIVERSAL ASEPTIC TRANSFER KIT HOUSINGJul 31, 2026MalfunctionZimmer Surgical Sa0008031000-2026-00044
- POWER MODULE FOR TRAUMA RECON SYSTEMJul 29, 2026MalfunctionSynthes Gmbh8030965-2026-07824
- X SERIES ASEPTIC BATTERY HOUSINGJul 15, 2026MalfunctionZimmer Surgical Sa0008031000-2026-00042
- POWER MODULE FOR TRAUMA RECON SYSTEMJul 9, 2026MalfunctionSynthes Gmbh8030965-2026-06960
- POWER MODULE FOR TRAUMA RECON SYSTEMJul 7, 2026MalfunctionSynthes Gmbh8030965-2026-06865
- POWER MODULE FOR TRAUMA RECON SYSTEMJul 6, 2026MalfunctionSynthes Gmbh8030965-2026-06820
- UNIVERSAL ASEPTIC TRANSFER KIT HOUSINGJul 3, 2026MalfunctionZimmer Surgical Sa0008031000-2026-00040
- UNIVERSAL ASEPTIC TRANSFER KIT HOUSINGJul 3, 2026MalfunctionZimmer Surgical Sa0008031000-2026-00041
- POWER MODULE FOR TRAUMA RECON SYSTEMJul 1, 2026MalfunctionSynthes Gmbh8030965-2026-06758
- POWER MODULE FOR TRAUMA RECON SYSTEMJul 1, 2026MalfunctionSynthes Gmbh8030965-2026-06756
Event type breakdown
Recalls
6 recall events for this product code
- Pro-Dex IncOpen, ClassifiedOct 31, 2024
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD
The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek shavings inside the sterile package.
Z-0280-2025 · View FDA record ↗ - Pro-Dex IncTerminatedMar 11, 2016
Battery Pack
The sterile battery may contain particulates within the sterile package.
Z-1094-2016 · View FDA record ↗ - Pro-Dex IncTerminatedMar 11, 2016
Battery Pack
The sterile battery may contain particulates within the sterile package.
Z-1095-2016 · View FDA record ↗ - Lumiport, LLCTerminatedNov 7, 2006
DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC.
Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.
Z-0156-2007 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
Universal Battery Charger II (UBC II)
The device is reported to enter safe mode and is no longer able to charge batteries.
Z-1994-2016 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Anspach Effort Inc.
Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, REV" instead of "ON, LOCK, ON".
Z-2126-2016 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Anybattery, Inc
Rosemount, MN, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Rrc Power Solutions Gmbh
Homburg /Saar Saarland, DE
Retail Acquisition & Development Dba Interstate All Battery
Urbandale, IA, US
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
The Anspach Effort, Inc.
Palm Bch Gdns, FL, US
Kerr Corporation
ORANGE, CA, US
Baeramed Instrumente Gmbh
SCHWENNINGEN Baden-Wurttemberg, DE
Evergreen Orthopedic Research Lab
Kirkland, WA, US
Linvatec Corporation
LARGO, FL, US
Depuy Synthes Sales
Bridgewater, MA, US
Artisan Power Llc Manufacturing
Hsin Chuang District New Taipei, TW
Insurgical, Inc.
Austin, TX, US
Synthes Gmbh / Synthes Produktions Gmbh
Oberdorf, Baselland Basel-Landschaft, CH
Cole Instruments
Alpharetta, GA, US
Ringele Ag
Pratteln Basel-Landschaft, CH
Microaire Surgical Instruments Llc
CHARLOTTESVILLE, VA, US
Sterigenics U.s., Llc
Corona, CA, US
Polyrack Science & Technology Co. Ltd.
Shenzhen Guangdong, CN
Isonic Inc.
Chicago, IL, US
Stryker Manufacturing Kalamazoo
Portage, MI, US
Unipower Corp.
Minnetonka, MN, US
Stryker Instruments
Portage, MI, US
Synthes Gmbh
Zuchwil Solothurn, CH
510(k) clearances
3 clearances for this product code